EndoForce Post Approval Study

Date Added
December 11th, 2025
PRO Number
Pro00147536
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.

Institution
MUSC Health Orangeburg
Recruitment Contact
Kristen Covington
803-395-2021
covingkr@musc.edu

An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients with Moderately to Severely Active Crohn's Disease (VECTORS)

Date Added
December 11th, 2025
PRO Number
Pro00147428
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Date Added
December 10th, 2025
PRO Number
Pro00147707
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD)
Summary

This study will see if the experimental medicine MTX-463 can slow or stop idiopathic pulmonary fibrosis (IPF) from worsening in people at least 40 years of age or older. Participants will receive either MTX-463 or a placebo (which contains no active drug) through an intravenous infusion once every 4 weeks, for a total of 6 infusions. Overall, participants will attend a total of 9 visits over the course of approximately 32 weeks, or roughly 8 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)

Date Added
December 9th, 2025
PRO Number
Pro00148422
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.

This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.

Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)

Date Added
December 9th, 2025
PRO Number
Pro00147257
Researcher
Ashley Waring

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with risk factors for heart or blood vessel events (e.g. heart attack, stroke, etc) who also have an elevated lipoprotein a (Lp(a)), which is a sticky particle in the blood that carries cholesterol. The first part of the study involves testing the Lp(a) level and if elevated then participants will be invited to be a part of a study testing the investigational medication olpasiran. Investigational means it has not been approved for commercial use by the Food and Drug Administration. The study medication is given as a shot just under the skin every 3 months. This study is a randomized study meaning participants are assigned by chance to either receive olpasiran or placebo. Placebo looks like the real medication but has no active ingredients. Participants have a 50:50 chance of being assigned to either group but will not know which group they are in. Study related procedures include physical exams, blood work, vital signs, electrocardiogram (ECG - a tracing of the heart's electrical activity) and study medication administration. This study is expected to last about three and a half to five and a half years and involve between 16 to 28 visits.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
Washoliv@musc.edu

Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)

Date Added
December 5th, 2025
PRO Number
Pro00147881
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate the performance of the Merit Medical WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY device). The WRAPSODY device is used to treat a blocked or narrowed vein you have in your dialysis access circuit that affects your blood flow during dialysis (treatment that removes waste and excess fluid from your blood).

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

Internal Barriers to Engaging in Medication Treatment for Opioid Use Disorder

Date Added
December 5th, 2025
PRO Number
Pro00147876
Researcher
Sara Witcraft

List of Studies

Keywords
Substance Use
Summary

This project aims to identify and evaluate internal barriers that inhibit engagement with pharmacological treatment for opioid use disorder (OUD). Participants, consisting of adults diagnosed with OUD, will complete a series of surveys that will take approximately 30 minutes. In conducting this study, investigators intend to identify barriers that could be improved by future interventions.

Institution
MUSC
Recruitment Contact
Sara Witcraft
843-792-3577
witcraft@musc.edu

Sex differences in neurobehavioral response to acute THC in adults with cannabis use disorder

Date Added
December 2nd, 2025
PRO Number
Pro00148223
Researcher
Erin Martin

List of Studies

Keywords
Substance Use
Summary

This study will examine sex differences in how the brain processes reward in people that regularly use cannabis. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1.5-hour brain scan.

Institution
MUSC
Recruitment Contact
Erin Martin
843-876-3528
marterin@musc.edu

AYA Access: An Enhanced eHealth and Chat-Bot Enabled Delivery Model for Clinical Genetic Services in Community AYA Cancer Patients

Date Added
December 2nd, 2025
PRO Number
Pro00147923
Researcher
Kevin Hughes

List of Studies

Keywords
Cancer, Genetics
Summary

This study is for adults aged 18 to 39 who have a history of cancer and have not had inherited cancer genetic testing. The purpose of this study is to find out if a digital tool can be used as an alternative to meeting with a genetic counselor before inherited cancer genetic testing, and whether this approach can help support patients through the testing process. The study will compare the digital tool to the usual approach for genetic testing, which involves meeting with a genetic counselor before and after testing.

Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive pre-test education through a digital tool, and the other group will meet with a genetic counselor through a telehealth visit. All participants will receive their genetic test results through a telehealth visit with a genetic counselor. Participants in the digital tool group will also have access to a chatbot called the Genetics Journey Chatbot that provides educational support, reminders, and answers to questions during the study.

The study involves completing surveys at several time points: before genetic testing, after the testing decision, after receiving results, and again about 6 and 12 months later. The total duration of participation is about 18 months.

This study does not involve an investigational drug. Participants may benefit from learning whether they have a genetic change that could increase their risk of cancer, which could inform their future screening or prevention options. The information learned from this study may also help improve genetic testing delivery for future patients.

There will be a total of 10 patients enrolled locally over the course of 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Characterizing Hemp-Derived Alternative Cannabinoid Product Use

Date Added
November 26th, 2025
PRO Number
Pro00147471
Researcher
Ashley Dowd

List of Studies

Keywords
Substance Use
Summary

The goal of the current project is to gather preliminary data from adults across the United States using an online survey study regarding alternative cannabinoid use, motivations, and experiences. We will also conduct interviews with some participants to gather more open-ended responses regarding the targets of interest in order to inform future work about alternative cannabinoids.

Institution
MUSC
Recruitment Contact
Ashley Dowd
843-792-5819
dowdas@musc.edu



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