Outcomes for VersaCoreTM Hydrogel Technology (VersaWrap® Tendon Protector, VersaCoatTM Tendon Protector) 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 Multicenter Randomized Trial of EBUS-TBNA versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing: FROSTBITE-3

Date Added
March 18th, 2025
PRO Number
Pro00140380
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Lung, Pulmonary
Summary

This study is for patients scheduled for a bronchoscopy, a procedure that allows doctors to examine lungs and airways for evaluation of suspicious lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups based on the Rapid On Site Evaluation of the initial sample obtained by the doctor performing the bronchoscopy as part of the standard of care procedure for the patient. the potential groups the subject will be randomized into are: Cryoprobe or transbronchial biopsy needle. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. 7 days following the procedure, a member of the study team will check the subjects medical chart to assess whether any adverse events have occurred.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Sleep and Activity Habits of Inpatients with Chest Tubes: A Pilot Observational Trial

Date Added
April 9th, 2025
PRO Number
Pro00140546
Researcher
Christopher Gilbert

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.

This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.

Institution
MUSC
Recruitment Contact
Randal Neff
8437924557
Neffr@musc.edu

A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (Prevail Global)

Date Added
July 8th, 2025
PRO Number
Pro00144658
Researcher
Christopher Nielsen

List of Studies


Keywords
Heart
Summary

This study is evaluating the clinical safety and efficacy of Prevail Drug-Coated Balloon (DCB) in the treatment of in-stent restenosis (ISR) which is the narrowing of heart arteries (blood vessels) previously treated with stents (mesh like medical device that helps keep arteries open) and in new narrowing of arteries in small vessels. The DCB is a small balloon that has medication on it. The medication is designed to reduce the re-occurrence of narrowing in blood vessels. All participants who have a previous stent will be chosen at random to be treated with either the Prevail DCB or the Agent DCB. You will have a 50:50 chance of being assigned to either DCB. The Prevail DCB is considered investigational meaning it has not yet been approved by the Food and Drug Administration (FDA). The Agent DCB is FDA approved. If you are being treated due to a new lesion in a small blood vessel, you will be treated with the Prevail DCB. Study related procedures include the following: electrocardiograph (known as an ECG, which is a test that shows your heart's electrical activity), blood draws, physical examinations, a review of chest pain, and medication history. Participation in this study will take about 5 years and include about 9 visits. Risks include risks related to the DCBs including allergic reaction, GI symptoms or changes to blood counts.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or Without Cemiplimab (REGN2810) for Participants Previously Treated with Platinum-based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Date Added
January 15th, 2026
PRO Number
Pro00149083
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.

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

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination with Immune Checkpoint Inhibition in Participants with Locally Advanced or Metastatic Refractory Solid Tumors

Date Added
March 12th, 2026
PRO Number
Pro00149087
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Gynecological, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with locally advanced or metastatic solid tumor, including non-small cell lung cancer (NSCLC), triple-negative breast cancer, gastric cancer, esophageal cancer (or gastroesophageal cancer), head and neck squamous cell cancer, ovarian cancer, endometrial cancer, or cervical cancer. The study is testing and investigational drug called NRM-823. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety and tolerability of NRM-823 as monotherapy and in combination with pembrolizumab. The study drug is given as an injection into the stomach (or another place, like the thigh). An injection is like a shot between the skin and muscle so that the drug can enter your body. Participants can expect to be on this study until the first radiographic disease progression.

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



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