A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia

Date Added
November 1st, 2022
PRO Number
Pro00122683
Researcher
Puja Elias

List of Studies


Keywords
Cancer/Gastrointestinal, Esophagus, Non-interventional, Surgery
Summary

The study will compare the effectiveness of endoscopic surveillance and endoscopic eradication therapy (EET) for the management of Barrett's esophagus (BE) and low-grade dysplasia (LGD).

Institution
MUSC
Recruitment Contact
Collins Ordiah
8438761912
ordiah@musc.edu

EvaLuate EndoVascular treatment of Acutely ruptured shallow intradural aneurysms with the Pipeline™ Flex Embolization Device with Shield TEchnology™ (ELEVATE)

Date Added
October 25th, 2022
PRO Number
Pro00116857
Researcher
Alejandro Spiotta

List of Studies


Keywords
Brain, Stroke, Surgery
Summary

ELEVATE is a device study that will look at the effectiveness of the Pipeline™ Shield Device in treating adults with acutely ruptured brain aneurysms that are shallow and are deemed unsuitable for treating with both clipping (placing a metal clip over the neck of the aneurysm) and coiling (stopping the blood flow into the aneurysm by packing it tightly with small pieces of metal). The primary goals for this study are a complete blocking of the blood vessel without narrowing of the blood vessel and no rebleeding or retreatment of the aneurysm through the 180-day follow-up.

After signing the consent subjects will be treated with the device which is a flow diverter (is a braided metal mesh cylinder that would be implanted across the opening (or ‘neck') of the aneurysm slow down or stop the blood flow into the aneurysm, causing the blood within the aneurysm to clot). The study will follow subjects from consent until the 365-day follow up post procedure. There are some risks associated with study participation such as death, stroke, and device failure. All other risks will be discussed with subjects at time of consent.

Institution
MUSC
Recruitment Contact
Emily Infinger
843-792-6210
infingem@musc.edu

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation

Date Added
September 13th, 2022
PRO Number
Pro00122442
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart, Surgery
Summary

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation. The PASCAL Transcatheter Valve Repair System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study participants will be randomized, meaning randomly assigned like drawing straws, in a 2:1 fashion to either receive the PASCAL Transcatheter Valve Repair System (treatment group) or optimal medical therapy (OMT) (control group). OMT means your medications will be adjusted as needed to provide the most benefit possible. Participants randomized to the OMT group may be eligible to receive the device after completing 2 years of follow up. Participants not eligible for randomization may be eligible for the registry portion of the study if approved by the sponsor. The registry arm participants will not be randomized but will undergo the procedure to place the device.

Participation in this study will last about 5 years and involve up to 15 visits for those in the treatment or registry group and 11 visit for those in the control group. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries

Date Added
August 4th, 2022
PRO Number
Pro00119228
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The types of balloons being studied in this clinical study is similar to other balloon devices that are routinely used in angioplasty procedures; however, it has a unique technology inside the balloon which is designed to deliver sonic energy (sound) to disrupt the hard, calcified elements of vascular blockages. With the balloon inflated at a low pressure, the probe will be activated to disrupt the calcium that is restricting the expansion of the artery.

Institution
MUSC
Recruitment Contact
ShaVon Capers
843-792-7244
caperssh@musc.edu

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)

Date Added
May 17th, 2022
PRO Number
Pro00119787
Researcher
Marc Katz

List of Studies


Keywords
Heart, Surgery
Summary

The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

BOLT: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Date Added
January 12th, 2022
PRO Number
Pro00115726
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this study is to observe the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to remove the clot from the deep veins.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

Date Added
November 23rd, 2021
PRO Number
Pro00114189
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. This study is collecting data on the safety and effectiveness of an investigational (not yet approved for commercial use by the US FDA (Food and Drug Administration)) device called the ACURATE Aortic Valve System. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems). Participants will be randomized (assigned by choice, like a flip of a coin, in a 1:1 fashion so 50% chance of being assigned to either group like the flip of a coin) to one of two groups. One group will receive the ACURATE Aortic Valve System while the other group will receive one of the commercially available systems. This study will last up to 10 years. Pre-procedure testing is done and reviewed by an eligibility committee to confirm you qualify. Study visits will occur prior to your procedure, during the procedure and throughout your hospital stay, and prior to discharge. Additional visits will occur 1 month and 6 months after your discharge, and then you will either seen or telephoned once per year for the next ten years. Study related testing includes CT scans, physical exams, echocardiograms (ultrasound test of the heart), blood work, and questionnaires.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Date Added
August 24th, 2021
PRO Number
Pro00112813
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Skin Tissue Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns

Date Added
July 6th, 2021
PRO Number
Pro00109484
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

The objective of this study is to evaluate the efficacy of augmenting traditional autografting with Stratagraft. Stratagraft is a synthetic human-tissue based regenerative skin device, which was designed to decrease the amount of donor tissue needed to treat severe burn wounds. Patients who participate in this study are asked to complete assessments, such as wound photography, wound healing progression, and scar progression, at multiple timepoints during a 1 year period.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

BATwire - Percutaneous Implant Kit

Date Added
June 8th, 2021
PRO Number
Pro00107572
Researcher
Jean Ruddy

List of Studies


Keywords
Heart, Surgery
Summary

Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu



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