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Displaying 1 - 16 of 16

Clinical Study of the Edwards Cardioband FIT Valve Repair System

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The Edwards Cardioband Tricuspid Valve Reconstruction FIT valve repair system is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for…
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CLASP II TR: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial in Patients with Tricuspid Regurgitation

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
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TTVR Early Feasibility Study in Patients with Symptomatic Severe Tricuspid Regurgitation - Medtronic

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood…
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Study of IW-3300 in Patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Condition: Urology
Investigator: Svjetlana Lozo, MD, MPH
Status: Closed
The purpose of this study is to find out if IW-3300, an investigational new drug, helps bladder pain when given as a rectal (inserted into the anus) foam. The study will test IW-3300. IW-3300 is a new drug that has been developed for treating people like you with interstitial cystitis/bladder pain syndrome. It is not yet approved by the United States Food…
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Echopulse for Treatment of Breast Fibroadenomas in Women

Condition: Surgery
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be…
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TRISCEND ll PIVOTAL Study of the Edwards EVOQUE Tricuspid Valve Replacement System

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart…
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Study of the Evoque System in People with Tricuspid Regurgitation (TRISCEND Study)

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
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Study to Reduce Lung Complications in Patients Undergoing Open Abdominal Surgery The PrimeAir Study

Condition: Surgery
Investigator: Marcos Vidal Melo, MD, PhD
Status: Closed
We are asking you to participate in a research study to learn if different ways of doing routine anesthesia and patient care before, during and after abdominal surgery can reduce breathing problems. The total time of the study is 3 months with daily visits by a member of our study team while you are in the hospital and 3 short follow-up calls after you…
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A study for adults with degenerative joint disease of the knee requiring total knee replacement using the Journey II CR Total Knee System

Condition: Surgery
Investigator: Jeffrey Geller, MD
Status: Closed
The purpose of this study is to evaluate the short-term (1 year) and long-term (5 and 10 year) safetyand effectiveness of the JOURNEY II CR Total Knee System in patients with degenerative joint disease of the knee requiring primary total knee replacement. Clinical, radiographic, and health economic outcomes will be evaluated.
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Validation of electronic (web-based and smartphone) administration of measures of pelvic floor dysfunction

Condition: Urology
Investigator: Doreen Eleanor Chung, MD
Status: Closed
You will be randomly assigned to complete questionnaires via either a paper format, web-based format, or smartphone format. About 2 weeks later but before treatment begins, you will be asked to complete a different form of the questionnaire either in the office or at home. You will be emailed and/or called by research staff to remind you to complete the…
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PRESERVE

Condition: Surgery
Investigator: Nicholas Morrissey, MD
Status: Closed
You are being asked to be part of this study because you have been diagnosed with a bulge or aneurysm in your iliac arteries, the vessels that supply blood to the lower half of your body. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk…
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A study assessing the study device, InSpace device, for treatment of massive rotator cuff tears

Condition: Surgery
Investigator: William Levine, MD
Status: Closed
The study is designed to evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for a full thickness Massive Rotator Cuff Tears (MRCT) in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
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A study for patients with Peripheral Artery Disease (PAD) using two of two drug-eluting stents

Condition: Surgery
Investigator: Danielle Bajakian, MD
Status: Closed
The purpose of this research study is to compare the safety and effectiveness of two drug-eluting stents that are used to open the blocked or narrowed blood vessel of the leg in patients with Peripheral Artery Disease (PAD): the ELUVIA Stent and the Zilver PTX Stent.
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A study for patients with bladder cancer using the Cysview and blue light system to detect tumors in order to prevent reoccurence

Condition: Urology
Investigator: Joel DeCastro, MD, MPH
Status: Closed
The purpose of the study is to investigate if Cysview and blue light is better than white light in detecting tumors in individuals with bladder cancer prior to and during surgery that are in follow-up for tumor recurrence. Cysview is an FDA approved drug that is used in combination with a lamp from KARL STORZ to detect tumors in the bladder (KARL STORZ D-…
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A study for patients who have had Cardiac surgery using study drug QPI-1002

Condition: Surgery
Investigator: Michael Argenziano, MD, FACS
Status: Closed
Thepurposeof the study is to test whether or not QPI-1002 could be used to lessen or prevent acute kidney injury after heart surgery. Another purpose is to better understand the safety of QPI-1002.
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A registry for patients with Overactive Bladder (OAB)

Condition: Urology
Investigator: Matthew Rutman, MD
Status: Closed
This study is for adults with Overactive Bladder. The purpose of this registry is to collect information about patients who have Overactive Bladder (OAB) and who are receiving either mirabegron or another approved antimuscarinic medication (single drug). To collect this information, the study Sponsor has created a research registry. A registry is a kind of…
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