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

Shockwave assisted large bore access (TAVR, TEVAR, EVAR, FEVAR)

Date Added
May 11th, 2021
PRO Number
Pro00109540
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this research study is to gather information on the health outcomes of patients who receive treatment with the Shockwave Medical, Inc Peripheral Lithoplasty® (Shockwave device) to assist with aortic endovascular procedures requiring a large catheter (long, thin tube made from medical grade materials). An endovascular procedure is a procedure where a doctor uses a small cut to insert a catheter into a blood vessel to repair it. The Shockwave Medical, Inc Peripheral Lithoplasty® system is an FDA approved catheter device used to open narrowed blood vessels in the legs (called arteries) so that it is easier for blood and other catheters to pass through. This study will collect information from participants who need an endovascular procedure on their aorta. The small cut used to insert the catheter is usually made in an artery in your leg and is used to get to your aorta. Endovascular procedures on the aorta use large catheters. Sometimes, it is necessary to expand the blood vessel in your leg so that the large catheters can fit. There are many different methods used clinically for this purpose, but it is not known which method works best. This study will help to determine if using the Shockwave device to expand your blood vessel is a better than using balloon angioplasty (use of a catheter with a balloon on the end) to expand your vessel

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

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Date Added
May 4th, 2021
PRO Number
Pro00105858
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Surgery
Summary

This study is testing a traditional Japanese medicine called Daikenchuto (TU-100) for restoring gastrointestinal function after bowel resection surgery. Subjects will be randomized to either TU-100 or placebo for up to 10 days after surgery and will be followed for 30 days after surgery.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation

Date Added
April 27th, 2021
PRO Number
Pro00109240
Researcher
Jonathan Halford

List of Studies


Keywords
Spinal Cord, Surgery
Summary

The purpose of this study is to test a new device called VerTouch. This is a handheld device that is designed to help the doctor perform the LP. LP is a Lumbar Puncture and is also known as a spinal tap. It is a medical procedure in which a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid for diagnostic testing. The main reason for a lumbar puncture is to help diagnose diseases of the central nervous system, including the brain and spine. An EAI is an epidural anesthesia procedure that delivers medicines that numb parts of your body to block pain. They are given through shots in or around the spine.The regular way to perform the LP and EAI procedure is for the doctor to feel the patient's back with their hands to find the location of the bones of the spine, and then insert a needle between the spinal bones into the body area near the theca sac (for the EAI procedure) or into the thecal sac, where the spinal fluid is (for the LP procedure). The Vertouch device has an electronic system which feels the pressure of the skin around the back, and shows the doctor a picture of where the bones of the spine may be. This may help the doctor insert the needle between the bones more accurately. The device just creates an image of the underlying structure; it does not guide the user to any particular spot within that image (beyond the user being instructed to pick the lowest pressure area between SPs, to put it simply). So the device itself does not do any decision-making in regard to how the procedure is performed.

The purpose of this study is to measure if the Vertouch device helps the doctor perform the LP and EAI procedures more quickly and accurately. This study plans to include approximately 96 patients at 3 different hospital, with 32 of those patients being at MUSC.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
bulgarino@musc.edu

A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Date Added
April 21st, 2021
PRO Number
Pro00106141
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular, Diabetes, Heart, Kidney, Surgery
Summary

The goal of this study is to find out if an investigational drug called ASP1128 (also called as MA-0217) is effective and safe as a treatment to prevent acute kidney injury (AKI) and/or reduce its severity in people who are at risk for AKI after heart surgery when compared to placebo (inactive substance). Researchers will look at how ASP1128 can act in the body.

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

Randomized Multi-Center, Subject and Evaluator Blinded, Parallel- Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study

Date Added
February 23rd, 2021
PRO Number
Pro00106547
Researcher
Marcelo Guimaraes

List of Studies


Keywords
Kidney, Liver, Surgery, Vascular
Summary

This study aims to investigate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared to the standard of care TAE/cTACE to treat a tumor by reducing or completely closing off the arterial blood supply to the tumor. The Instylla HES is an experimental treatment. Subjects will be evaluated for 180 days following the embolization procedure. At each visit, subjects will be asked to complete at least one quality of life questionnaire, undergo a physical assessment (vitals only), blood test to check blood cell levels, and follow-up tumor imaging. Throughout the duration of the study, subjects will be evaluated for complications or side effects that may be related to the procedure and/or Instylla HES device. This study will be conducted at up to 20 sites in the U.S. with additional sites outside of the U.S. It is anticipated that the full investigation will take approximately 2 years.

Institution
MUSC
Recruitment Contact
Elizabeth Kelley
843-792-2305
kelleyel@musc.edu

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Date Added
February 9th, 2021
PRO Number
Pro00104312
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

EVALUATION OF A PILOT IMPLEMENTATION OF A REMOTE WOUND MONITORING (RWM) PROGRAM FOR POST-OPERATIVE WOUND TRIAGE

Date Added
January 13th, 2021
PRO Number
Pro00092656
Researcher
Heather Evans

List of Studies


Keywords
Disease Prevention, Surgery
Summary

Patients who undergo elective colorectal surgery are at high risk for post-operative surgical site infection, and the majority of SSIs occur after hospital discharge when patients are responsible for their own wound care. A novel approach to post-discharge wound evaluation is Remote Wound Monitoring, a novel platform implemented through MUSC Health's established telehealth infrastructure, based on the successful implementation of Remote Patient Monitoring (RPM) for COVID-19 symptoms. This program was recently developed to enable patients to submit wound care observations and wound photos via MyChart at regular intervals after hospital discharge. Telehealth nurses review patient generated wound images, and brief survey responses from patients using a mobile smartphone, escalating any concerning findings to colorectal surgery clinic staff. The goal of the present study is to refine the RWM program using interviews and questionnaires with those who have used RWM in practice, including patients and colorectal surgery providers, to make the MyChart based questionnaire more "user-friendly." The RWM platform was designed to bring post-operative wound triage directly to the patient's home to address barriers to healthcare, including high cost, burden and time commitment (e.g., geographic limitations, transportation, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. During this project, we will perform semi-structured interviews of stakeholders who have used the RWM service in practice, including patients, colorectal surgery providers and telehealth nurse monitors, and administer measures of satisfaction/usability and patient quality of life, followed by consumer-driven adjustments to the service to ensure high acceptability and usability. Refinement will be aimed at improving patient adherence as well as provider barriers to implementation. The proposed project will aid in the development of technology-based resources that (1) improve the quality of and access to post-operative wound triage for surgical patients and (2) relieve the burden on surgical provider by shifting primary triage of wounds to the telehealth remote patient monitoring team, and facilitating escalation of care when wounds veer from expected post-operative healing. RWM has significant clinical utility and strong potential to influence access to care and alter the doctor-patient relationship, enabling healthcare providers to prescribe the right intervention at the right dose at the right time for each patient.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-492-8824
hirschj@musc.edu

A pilot trial to determine the effective dose of N-acetylcysteine for opioid reduction in patients undergoing spine surgery.

Date Added
August 18th, 2020
PRO Number
Pro00099062
Researcher
Sylvia Wilson

List of Studies


Keywords
Surgery
Summary

This study is being done to determine if N-acetylcysteine (NAC) will reduce the amount of pain medications needed after some types of spinal surgeries.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

Utilization of quadratus lumborum versus lumbar plexus blocks for postoperative analgesia following hip arthroplasty: A prospective, randomized clinical trial.

Date Added
April 21st, 2020
PRO Number
Pro00098482
Researcher
Sylvia Wilson

List of Studies


Keywords
Surgery
Summary

The purpose of this research study is to find out if a nerve block called the quadratus lumborum (QL) block can provide pain relief after hip replacement, similar to a lumbar plexus (LP) nerve block that we currently offer patients. There will be two groups in this study: one group will have the QL block placed and the other group will have the LP block placed.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu



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