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Displaying 1 - 6 of 6

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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AXONICS: a study of Sacral Neuromodulation (SNM) therapy for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI).

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety and effectiveness of a device called the Axonics SNM System in reducing symptoms for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI). The study will enroll up to 130 participants at up to 20 sites in the United States and Western Europe. The Axonics System delivers mild electric…
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BOOM-IBD2: A study of sacral neuromodulation (SNM) for the treatment of Inflammatory Bowel Disease (IBD)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and…
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Study of C2 CryoBalloon Focal Ablation System for Patients with Barrett's Esophagus

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Currently Recruiting
This research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
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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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