Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal Study

Date Added
March 4th, 2026
PRO Number
Pro00148886
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end stage renal disease (ESRD) and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min.

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

A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury

Date Added
April 15th, 2026
PRO Number
Pro00148577
Researcher
Nicolas Pope

List of Studies

Keywords
Critical Care
Summary

The purpose of this research is to look at the safety and tolerabilty of an experimental study drug called AZD4144 and its effect on Sepsis-Associated Acute Kidney Injury (SA-AKI). The main goal of this research is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.

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

Customized Repair for Extensive Aortic pathology using Thoracoabdominal Endografts (CREATE)

Date Added
June 16th, 2026
PRO Number
Pro00149865
Researcher
Ryan King

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this research study is to evaluate the safety and effectiveness of a
physician-modified endograft (tubular medical device used to reinforce weakened or damaged blood vessels) for repairing serious diseases of the aorta (largest artery in the human body, responsible for blood from the heart to the rest of the body). This device is considered investigational, and this research study received an Investigational Device Exemption (IDE) from the FDA.

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

Women's Aneurysm Research: Repair Immediately or Routine Surveillance: WARRIORS Trial- USA

Date Added
July 23rd, 2026
PRO Number
Pro00151293
Researcher
Jean Ruddy

List of Studies


Keywords
Surgery
Summary

This study is trying to find out whether early repair of small Abdominal Aortic Aneurysms (AAAs) in women improves health outcomes compared to routine monitoring. An AAA occurs when a section of the aorta in the abdomen weakens and bulges outward, resembling a balloon. This condition is serious because if the aneurysm ruptures, it can cause severe internal bleeding and can be fatal. This question is important because women with small AAAs may have a higher risk of rupture than men, and doctors are not yet sure whether early repair is better than standard monitoring. Surgical repair is the elective standard of care for aneurysms above 5.5cm in size. In our study we are evaluating if earlier repair (between 4.0- 5.4 cm) might be beneficial to women with abdominal aneurysms, but it is important to note that surgical repair involves risks and could lead to other complications, including death. These risks are discussed later in this form. There is also the possibility that you may need additional procedures, including open surgery.

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

ColoSeal™ ICD System Anastomotic Protection Pivotal Study

Date Added
July 31st, 2026
PRO Number
Pro00150028
Researcher
Maggie Westfal

List of Studies

Keywords
Surgery
Summary

Adult subjects with rectal cancer undergoing sphincter sparing resection and colonic anastomosis. Post-operative follow-up will occur at 7-10 days, 30 days, 90 days, 180 days, and 270 days.

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

A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus–Associated Nephropathy Following Kidney Transplantation

Date Added
August 12th, 2026
PRO Number
Pro00150730
Researcher
Sakshi Vaishnav

List of Studies

Keywords
Surgery
Summary

This is a prospective, multicenter, observational study designed to evaluate the clinical utility and prognostic relevance of serial TRAC and T-ID monitoring in kidney transplant recipients under routine clinical care.

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

Maturation of Arteriovenous Fistula with Automated Sonography Assessments (MAFASA) Trial

Date Added
August 13th, 2026
PRO Number
Pro00149409
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this research is to evaluate the safety and effectiveness of the EchoMark/EchoSure System for AVF (arteriovenous fistula) for assessing AV fistula maturation when used under a protocol of biweekly use as compared to the standard of care follow-up. Target subject population are subjects presenting with Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) undergoing upper arm autologous arteriovenous fistula creation for hemodialysis access who are on dialysis or will imminently require dialysis (GFR <10).

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



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