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.
Trials |
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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.
Some 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.
NCT02694809 STU00202100 |
NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated BreastThe 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. Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiation
NCT04009044 STU00208708 |
Partner 3 AVIV RegistryThis 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. |
APOLLOThis 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. Enrolling 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.
NCT03242642 STU00206197 |
CLASP IID/IIFThe 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. Primary Inclusion Criteria:
NCT03706833 STU00208635 |
REPAIR-MRThe 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.
NCT04198870 STU00211557 |
TRISCEND IIThis 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. |
Precision MRI of Left Atrial Fibrosis for Patients with Atrial FibrillationTo 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 Primary Inclusion Criteria:
Primary Exclusion Criteria:
STU00213834 |
RESPONDER-HFRe-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure
NCT05425459 STU00217812 |
ARISE-IIEvaluation of the GORE® Ascending Stent Graft (ASG device) in the Treatment of Lesions of the Ascending Aorta
NCT05800743 STU00219695 |
Preserve Heart StudyStudy of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors Listed for heart transplantation
NCT05881278 STU00220133 |
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.
NCT01897688 STU00059469 |
TAMBE Pivotal AAA 17-01This 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. |