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

A Pilot Study Examining Conscious Awareness and Cognitive Experiences During Deep Hypothermic Circulatory Arrest

Date Added
July 14th, 2020
PRO Number
Pro00095824
Researcher
Sanford Zeigler

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to examine if patients undergoing cardiac surgery have memories and thought processes during the surgery while unconscious. Participants' brain electrical activity will be monitored during surgery using an EEG. A portable tablet will show random images to participants and participants will wear headphones that will generate audio cues during surgery. After recovery from surgery, participants will undergo a 45 minute interview to assess any memories or experiences during surgery.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@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

Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children with Inflammatory Bowel Disease

Date Added
March 25th, 2020
PRO Number
Pro00098243
Researcher
Robert Cina

List of Studies


Keywords
Pediatrics, Surgery
Summary

This study will implement and evaluate the Enhanced Recovery in Children Pathway (ENRICH-P) for pediatric patients with inflammatory bowel disease. Participants (or participants' parent) will be asked to complete quality of life surveys pre-operatively and up to 6 weeks after surgery.

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

Use of NexoBrid for Treatment of Acute deep partial and full thickness Burn Injuries

Date Added
March 24th, 2020
PRO Number
Pro00095953
Researcher
Steven Kahn

List of Studies


Keywords
Surgery
Summary

This is an Expanded Access (treatment) protocol to expand treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study). This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from deep partial thickness (DPT) and full thickness (FT) thermal burns. Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns. Patients enrolled in this trial will undergo daily vital signs and pain assessments for 1 week starting on the morning after the start of treatment. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed. There will also be a scar quality evaluation at 3 and 12 months post wound closure confirmation visit.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Peri-operative Exposure to Plasticizers in Newborns Undergoing Cardiac Surgery

Date Added
March 18th, 2020
PRO Number
Pro00087955
Researcher
Eric Graham

List of Studies


Keywords
Heart, Surgery
Summary

This is a prospective observational study which collects urine samples for testing. The goal of this study is to measure how much plastic from medical equipment shows up in the baby's urine.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

Treatment of Symptomatic Spondylolysis and Spondylolisthesis

Date Added
March 2nd, 2020
PRO Number
Pro00092708
Researcher
Robert Murphy

List of Studies


Keywords
Pain, Surgery
Summary

Spondylolysis and spondlyolisthesis are rare conditions in children and adolescents. The long term outcomes of treating these patients are unknown. The purpose of this study is understand the symptom relief and quality of life of this patient population.

Institution
MUSC
Recruitment Contact
Robert Murphy
843-792-9542
murphyr@musc.edu



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