A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)

Date Added
November 12th, 2025
PRO Number
Pro00145701
Researcher
Erik Hansen

List of Studies

Keywords
Arthritis, Bone, Surgery
Summary

This study is designed to assess the 10-year post-surgery implant survivorship of Total Knee Arthroplasty (TKA) procedures performed using the LEGION Medial stabilized insert, which is FDA approved. Implant survivorship is defined as all of the knee-implanted components without a need for a revision. Questionnaires will be used up to 10 years after surgery to find more about the safety and performance of the device.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-0111
mockl@musc.edu

A Prospective Multicenter Single-arm Clinical Study Investigating Clinical Outcomes when Cohealyx™ is used for the Management of Full Thickness Wounds Post-surgical Excision

Date Added
October 7th, 2025
PRO Number
Pro00146533
Researcher
Steven Kahn

List of Studies


Keywords
Surgery
Summary

This is a prospective single-arm post-market multicenter study to evaluate
clinical outcomes of Cohealyx when used to manage full thickness wounds
post-surgical excision. Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will
undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury. Once Cohealyx has successfully integrated into the wound bed, the wound will be prepped and autografted per standard of care.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

A Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair

Date Added
August 27th, 2025
PRO Number
Pro00145325
Researcher
Charles Daly

List of Studies

Keywords
Nerve, Surgery
Summary

The study is a 48-week clinical study to compare study medication NTX-001 used intraoperatively to promote nerve regeneration compared to the standard of care on surgery for acute nerve damage in the hand on subjects between the ages of 18 to 80 years old. Subjects who present with sever nerve damage of the hand and need surgery to repair the nerve damage within 48 hours of injury. After surgery, subjects will complete 12 total study visits: 6 in person and 6 additional telehealth visits. During the in-person clinic visits, subjects will be assessed by physical examinations, vital signs, safety laboratory assessment and complete questionnaires. Subjects with motor/mixed motor injury will also complete an EMG and NCV assessments with an Occupational Therapist at 2 of the in-person visits. During the telehealth visits, subjects will complete questionnaires.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)

Date Added
May 15th, 2025
PRO Number
Pro00143150
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular, Heart, Surgery
Summary

The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
(843) 792-8522
dehoff@musc.edu

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

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

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Date Added
February 25th, 2025
PRO Number
Pro00140492
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.

Institution
MUSC
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Date Added
February 25th, 2025
PRO Number
Pro00141297
Researcher
Anbukarasi Maran

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects with coronary artery disease (blockages in the arteries that supply blood to the heart) who need to undergo a procedure called a Percutaneous Coronary Intervention (PCI) to open up a blocked heart artery. At times, a heart pump is used during a PCI to help reduce the work the heart during the procedure. This study is evaluating a heart pump called the KARDION CORY P4 pump. The KARDION CORY P4 pump is investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). This study will randomize subjects, meaning assign by chance, to receive either the KARDION CORY P4 pump or the Impella CP, which is commercially available.

Study participation will last about 30 days and include up to 6 visits. The study includes blood work, questionnaires, an electrocardiogram (ECG) - a tracing of the heart's electrical activity and an echocardiogram (Echo) - an ultrasound test of the heart.

Risks include risks related to the study device including bleeding, infection, and injury to the blood vessel where the device is placed. There are also risks related to study procedures. There may be benefit and the information learned may benefit others in the future.

Institution
MUSC
Recruitment Contact
Virginia Theodorof
843-876-9078
theodoro@musc.edu

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Date Added
January 14th, 2025
PRO Number
Pro00141768
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the PulseSelect™ PFA System which is approved by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 2 years and include up to 6 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

Outcomes for VersaWrap® in Achilles Tendon Repair

Date Added
January 2nd, 2025
PRO Number
Pro00136177
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Bone, Joint, Pain, Surgery
Summary

The purpose of this study is to determine the clinical efficacy of a novel, bioresorbable hydrogel sheet and wetting solution, VersaWrap®, in surgeries of the foot and ankle. This is a prospective, multi-center, controlled case series with patients identified by the Investigator in his practice. Patients who are scheduled to have procedures of the Achilles tendon will be reviewed to determine if they meet the inclusion/exclusion criteria. If eligible, patients may be enrolled in the study, and the operative surgeon will use VersaWrap® during the procedure. Patients are considered enrolled when VersaWrap® is placed intraoperatively. VersaWrap® has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1-2 years. All subjects will be followed for 1 year post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 6 weeks, 3 months, 6 months, and 1 year after surgery. Patients enrolled in this study are receiving a standard of care surgical procedure (with or
without VersaWrap) and therefore there is no increased risk of the surgical procedure when participating in the study. The study collects patient data, and therefore there is a risk data privacy loss. Patients will also receive remuneration for their participation.

Institution
MUSC
Recruitment Contact
Jagan Kandadai
2148422519
kandadai@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Post-Operative Steroids after Sleep Surgery

Date Added
December 3rd, 2024
PRO Number
Pro00138969
Researcher
Mohamed Abdelwahab

List of Studies

Keywords
Pain, Sleep Disorders, Surgery
Summary

The purpose of this study is to study the effectiveness of steroids after sleep surgery in improving pain, reducing difficulties in swallowing, and reducing the amount of narcotic pain medication after surgery. This study also want to see what dosage of steroids, whether intravenous or oral, are more effective at reducing these symptoms and providing a more effective surgical procedure for your sleep apnea. Anyone planning to undergo sleep surgery for your obstructive sleep apnea at the recommendation of the Sleep Surgery Division here at MUSC is invited to participate in this study. The study will be using both intravenous and oral dexamethasone, a very common and widely used steroid. This steroid has been FDA approved for many medical indications.

Institution
MUSC
Recruitment Contact
Nicolas Poupore
843-792-8299
poupore@musc.edu



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