Clinical Trials

As part of an academic medical center, the Department of Surgery at Northwestern University Feinberg School of Medicine aims to improve the human health through scientific research.

Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

The following searchable list includes all Department of Surgery clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

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Trials
A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ. … The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS. Eligibility CriteriaSome of the eligibility criteria include: - Participants must be postmenopausal women with newly diagnosed DCIS scheduled to undergo surgical therapy. - Patients must be able to swallow the oral medication. - Patients must be able to understand and the willing to sign a written informed consent document and comply to all procedures. Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial. Principal Investigator Kulkarni, Swati Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT02694809IRB number STU00202100 More Info Email Study Coordinator Phone 312 695 1102 Copy Study URL to Clipboard Copy
NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause … The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause harmful effects to other organs. When tamoxifen is taken by mouth, it is broken down by the liver into two main active forms, one of which is 4-hydroxytamoxifen, also called 4-OHT. Tamoxifen is approved by the Food and Drug Administration (FDA) while 4-OHT is not and is, therefore, considered investigational. However, 4-OHT has anti-cancer activity, and has been developed as a quick drying medicated gel that can be applied to the breast skin. Early results from two previous studies show that 4-OHT gel, when applied to the skin, gets into the breast and blocks breast cancer cell growth as effectively as oral tamoxifen. Unlike oral tamoxifen, the gel is concentrated in the breasts and therefore very little tamoxifen reaches the blood or other parts of the body. Also, some women lack the proteins that are responsible for the break-down of tamoxifen. It is possible that the use of 4-OHT gel will be more effective than oral tamoxifen in these women. Eligibility CriteriaPatients who had radiation for breast cancer in one breast and their other breast has not undergone radiation Principal Investigator Khan, Seema Ahsan Location(s) Map it 250 E. Superior St. Chicago, IL ClinicalTrials.gov IdentifierNCT04009044IRB number STU00208708 More Info Keywords breast cancer tamoxifen Email Pulliam, Natalie E Phone +1 312 472 4767 Copy Study URL to Clipboard Copy
Partner 3 AVIV Registry This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace … This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally. Principal Investigator Malaisrie, S. Chris Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03003299IRB number STU00204739 More Info Keywords Aortic Valve Transcatheter Aortic Valve Replacement (TAVR) Email Murrin, Lauren Elizabeth Phone 312 926 1096 Copy Study URL to Clipboard Copy
APOLLO This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (… This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC). The new investigational device is a mitral valve replacement called the Medtronic IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The IntrepidTM TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 in-person scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure. Eligibility CriteriaEnrolling participants with mitral valve regurgitation who are at high risk of experiencing major complications while undergoing open-heart surgery due to their current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within the body). Additionally, physicians have determined that these participants may not be optimally treated with currently approved transcatheter repair therapies. Principal Investigator Malaisrie, S. Chris Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03242642IRB number STU00206197 More Info Keywords Mitral Valve Regurgitation (MVR) Transcatheter Mitral Valve Repair (TMVR) Email Murrin, Lauren Elizabeth Phone +1 312 926 1096 Copy Study URL to Clipboard Copy
CLASP IID/IIF The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for … The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team. Eligibility Criteria Primary Inclusion Criteria: Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab Left ventricular ejection fraction (LVEF) ≥ 20% Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03706833IRB number STU00208635 More Info Keywords Mitral Valve Regurgitation MVR Transcatheter Mitral Valve Repair TMVR MitraClip Email Murrin, Lauren Elizabeth Phone +1 312 926 1096 Copy Study URL to Clipboard Copy
REPAIR-MR The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less … The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve. Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward. The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm. Eligibility Criteria Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL. Subject is at least 75 years of age Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04198870IRB number STU00211557 More Info Keywords Heart Failure Heart Surgery Severe MR MitraClip MitralValve Repair Email Murrin, Lauren Elizabeth Phone +1 312 926 1096 Copy Study URL to Clipboard Copy
TRISCEND II This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if … This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation. Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04482062IRB number STU00213338 More Info Keywords Tricuspid Valve Transcatheter Email McCloskey, Elizabeth Marie Phone 312 926 0840 Copy Study URL to Clipboard Copy
Precision MRI of Left Atrial Fibrosis for Patients with Atrial Fibrillation To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure… To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure Eligibility Criteria Primary Inclusion Criteria: Patients ≥ 18 years old Patients with paroxysmal or persistent AF undergoing routine pulmonary vein isolation (PVI) Patients undergoing a cardiac MRI prior to AF ablation Primary Exclusion Criteria: Contraindication to MRI Abnormal renal function (eGFR < 60 mL/min/1.73 m2) Principal Investigator Kim, Daniel Location(s) Map it 710 N. Fairbanks Ct. Olson Pavilion Chicago, IL Map it 710 N. Fairbanks Court Chicago, IL IRB number STU00213834 More Info Keywords Atrial Fibrillation (Afib) Pulmonary Vein Isolation (PVI) MRI Catheter Ablation Email Paul, Rupsa Phone 312 926 5424 Copy Study URL to Clipboard Copy
PROACTIVE-HF Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System Eligibility Criteria Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of screening stable, optimally titrated medical therapy for at least 30 days HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NTproBNP) at time of Screening/ Enrollment defined as: Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL. Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL Principal Investigator Raza, Yasmin Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT04089059IRB number STU00216044 More Info Email Silverman, Andrea Raye Phone Copy Study URL to Clipboard Copy
RESPONDER-HF Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure Eligibility Criteria Chronic symptomatic heart failure (HF) Ongoing stable GDMT HF management and management of comorbidities according to the 2022 ACC/AHA Guidelines for the Management of Heart Failure. Principal Investigator Flaherty, James D Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05425459IRB number STU00217812 More Info Email Roshevsky, Daniel Scott Phone +1 312 695 3264 Copy Study URL to Clipboard Copy
RIVUS HuMAIN (RIV-HU6-2201) Exploratory Phase 2A, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of HU6 for the Treatment of Subjects with Obese Heart Failure with Preserved Ejection Fraction Eligibility Criteria Body mass index (BMI) ≥30 kg/m2 Signs and symptoms of HF in the judgement of the Investigator Ambulatory (not wheelchair- or scooter-dependent) and able to perform upright exercise testing including a 6 MWT Principal Investigator Shah, Sanjiv J Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05284617IRB number STU00217735 More Info Keywords Obese Heart Failure HFpEF Email DeTella, Mia Lizabeth Phone Copy Study URL to Clipboard Copy
Gore TAG-TBE This research study is recruiting patients who have one of the following conditions:1.A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2.A tear in your aortic wall (dissection). Blood flows … This research study is recruiting patients who have one of the following conditions:1.A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2.A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture.3.Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture.4.A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture.5.A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening conditionThe study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution. Eligibility Criteria Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2 Principal Investigator Hoel, Andrew Warfield Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT02777593IRB number STU00203850 More Info Keywords Aortic Aneurysm Aortic Dissection Intramural Hematoma Vascular Surgery Email Belback, Madeleine Rose Phone +1 312 503 5901 Copy Study URL to Clipboard Copy
A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS … Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes. Principal Investigator Borja-Cacho, Daniel ClinicalTrials.gov IdentifierNCT01897688IRB number STU00059469 More Info Keywords Diabetes Islet Pancreas Hypoglycemia T1D Transplant Copy Study URL to Clipboard Copy
ALL-IN This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) … This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational. Eligibility Criteria Patients who are about to have a heart transplant Principal Investigator Ghafourian, Kambiz Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03644667IRB number STU00212222 More Info Keywords Transplant Heart Transplant Actemra Tocilizumab Heart Failure Email Roshevsky, Daniel Scott Phone 312 695 3264 Copy Study URL to Clipboard Copy
TAMBE Pivotal AAA 17-01 This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research … This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research study will look at treating thoracoabdominal or pararenal aneurysm disease with a new device design known as the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (the ‘Study Device’).The Study Device that will be used to treat the aneurysm is called a “stent-graft”. The Study Device combines a surgical graft material with an outer metal mesh-like form (stent). The nonmetal graft component of the Study Device is made of a soft, polymer material (ePTFE). This material is routinely and safely used for surgical procedures throughout the world today. The graft is surrounded on the outside with a metal frame made from an elastic metal (nitinol wire or stainless steel) bent into a wave pattern and shaped to fit the graft. The materials used in the Study Device are not investigational and have a long, safe history of performance in similar applications. Principal Investigator Hoel, Andrew Warfield Location(s) Map it 201 E. Huron St. Suite 12 160 Chicago, IL ClinicalTrials.gov IdentifierNCT03728985IRB number STU00211408 More Info Keywords Abdominal Aortic Aneurysm Aneurysm Email Belback, Madeleine Rose Phone +1 312 503 5901 Copy Study URL to Clipboard Copy