Cochlear implant expectations

Date Added
August 21st, 2021
PRO Number
Pro00113247
Researcher
Joshua Fabie

List of Studies

Keywords
Ears, Hearing, Surgery
Summary

The study will include 9 key informant interviews discussing how patients developed their impression of the benefit of an implant and how patients prefer expectation data be relayed. No video recordings will be performed during interviews. Interview notes or audio recordings will be taken and uploaded into a password protected network server. The results of interviews will mainly be descriptive. To test the plasticity of preoperative patient expectations and the impact of the CI evaluation the CIQOL expectations form will be administered prior to CI evaluation, directly after the CI evaluation, and prior to surgery for all patients who are undergoing cochlear implantation and meet inclusion/exclusion criteria and agree to participate. The decisional conflict scale will also be administered directly after the CI evaluation and prior to surgery for the above patient group. The 9 patients who undergo key informant interviews will also be part of the larger study group of 200 patients and have the same surveys administered and be subject to the same inclusion/exclusion criteria. The group of patients will also be asked about how they prefer expectation and QOL data to be relayed. All survey data will be collected in a secure RedCap database. Patients expectations at the three preoperative timepoints will be compared using paired T-tests. Data regarding how patients develop expectations and how they prefer expectation data to be presented to them will be mainly qualitative and discussed in terms of the most common themes from patient surveys and interviews. When exploring how patients prefer expectations and QOL data to be relayed we intend to include numbered clinical vignettes relaying differing levels of hearing capability. We will compare relaying information through vignettes to more conventional outcome measures such as speech recognition and QOL scores to determine which is the more effective means of communication.

Institution
MUSC
Recruitment Contact
David Aamodt
843-876-7069
aamodt@musc.edu

Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature: The LAVA Study

Date Added
July 13th, 2021
PRO Number
Pro00111982
Researcher
D. Thor Johnson

List of Studies


Keywords
Surgery, Vascular
Summary

This purpose of this study is to evaluate a new device called Lava Liquid Embolic System (LES) in the treatment of peripheral arterial hemorrhage (active bleeding in vessels outside of the head, heart, spine, and vessels related to childbirth). As an investigational device, Lava LES is not FDA approved.
The Lava LES device provides a minimally invasive type of treatment inside the vessels called embolization therapy that reduces or blocks blood flow to blood vessels or organs in order to stop internal bleeding. Subjects who have hemorrhage (bleeding) in a peripheral artery, including arteries located in the gastrointestinal system (stomach, intestines), lungs, liver, pancreas, spleen, prostate, bladder, uterus, muscles, or other peripheral artery wound caused by medical intervention or trauma, may be eligible for treatment with Lava LES.
The primary effectiveness goal is clinical success. Clinical success is defined as absence of bleeding from the wounded vessel after embolization with the Lava LES, without the need for emergency surgery, repeat embolization, or other medical intervention at the wounded vessel within 30 days of the embolization procedure. Subjects will be evaluated for 30 days following the embolization procedure for complications or side effects that may be related to the procedure and/or Lava LES device. The primary safety endpoint is freedom from major adverse events for 30 days. This is a first-in-human investigational trial.
Subjects will complete 4 visits (screening, embolization procedure, discharge, and 30-day follow-up). The 30-day follow-up will be completed remotely (video call or phone call). Some visits may occur on the same day. Participation in the study is anticipated to last about 30 days following the embolization procedure.

Institution
MUSC
Recruitment Contact
Elizabeth Kelley
843-792-2305
kelleyep@musc.edu

A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Skin Tissue Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns

Date Added
July 6th, 2021
PRO Number
Pro00109484
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

The objective of this study is to evaluate the efficacy of augmenting traditional autografting with Stratagraft. Stratagraft is a synthetic human-tissue based regenerative skin device, which was designed to decrease the amount of donor tissue needed to treat severe burn wounds. Patients who participate in this study are asked to complete assessments, such as wound photography, wound healing progression, and scar progression, at multiple timepoints during a 1 year period.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

BATwire - Percutaneous Implant Kit

Date Added
June 8th, 2021
PRO Number
Pro00107572
Researcher
Jean Ruddy

List of Studies


Keywords
Heart, Surgery
Summary

Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.

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

A Prospective Multi-Arm Blinded Evaluator Within-subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for the Repigmentation of Stable Vitiligo Lesions

Date Added
May 24th, 2021
PRO Number
Pro00107906
Researcher
Steven Kahn

List of Studies


Keywords
Cosmetic Procedures, Skin, Surgery, Transplant
Summary

This is a randomized study to evaluate the clinical performance of RECELL for re-pigmentation of stable, de-pigmented skin in subjects 18 years or older. RECELL is a device that takes a small sample of skin from one location on the participant's body, processes that sample into a spray, and then applies that spray to the depigmented skin on the participant's body. Each participant will have some depigmented skin that is not treated by the RECELL device, so that a comparison can be made to the treated areas. The participant will be asked to return for a follow-up visit 1, 4, 12, 24, 36, and 52 weeks after their treatment, so that the research study team can assess their outcome.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

Shockwave assisted large bore access (TAVR, TEVAR, EVAR, FEVAR)

Date Added
May 11th, 2021
PRO Number
Pro00109540
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this research study is to gather information on the health outcomes of patients who receive treatment with the Shockwave Medical, Inc Peripheral Lithoplasty® (Shockwave device) to assist with aortic endovascular procedures requiring a large catheter (long, thin tube made from medical grade materials). An endovascular procedure is a procedure where a doctor uses a small cut to insert a catheter into a blood vessel to repair it. The Shockwave Medical, Inc Peripheral Lithoplasty® system is an FDA approved catheter device used to open narrowed blood vessels in the legs (called arteries) so that it is easier for blood and other catheters to pass through. This study will collect information from participants who need an endovascular procedure on their aorta. The small cut used to insert the catheter is usually made in an artery in your leg and is used to get to your aorta. Endovascular procedures on the aorta use large catheters. Sometimes, it is necessary to expand the blood vessel in your leg so that the large catheters can fit. There are many different methods used clinically for this purpose, but it is not known which method works best. This study will help to determine if using the Shockwave device to expand your blood vessel is a better than using balloon angioplasty (use of a catheter with a balloon on the end) to expand your vessel

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

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Date Added
May 4th, 2021
PRO Number
Pro00105858
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Surgery
Summary

This study is testing a traditional Japanese medicine called Daikenchuto (TU-100) for restoring gastrointestinal function after bowel resection surgery. Subjects will be randomized to either TU-100 or placebo for up to 10 days after surgery and will be followed for 30 days after surgery.

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

An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation

Date Added
April 27th, 2021
PRO Number
Pro00109240
Researcher
Jonathan Halford

List of Studies


Keywords
Spinal Cord, Surgery
Summary

The purpose of this study is to test a new device called VerTouch. This is a handheld device that is designed to help the doctor perform the LP. LP is a Lumbar Puncture and is also known as a spinal tap. It is a medical procedure in which a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid for diagnostic testing. The main reason for a lumbar puncture is to help diagnose diseases of the central nervous system, including the brain and spine. An EAI is an epidural anesthesia procedure that delivers medicines that numb parts of your body to block pain. They are given through shots in or around the spine.The regular way to perform the LP and EAI procedure is for the doctor to feel the patient's back with their hands to find the location of the bones of the spine, and then insert a needle between the spinal bones into the body area near the theca sac (for the EAI procedure) or into the thecal sac, where the spinal fluid is (for the LP procedure). The Vertouch device has an electronic system which feels the pressure of the skin around the back, and shows the doctor a picture of where the bones of the spine may be. This may help the doctor insert the needle between the bones more accurately. The device just creates an image of the underlying structure; it does not guide the user to any particular spot within that image (beyond the user being instructed to pick the lowest pressure area between SPs, to put it simply). So the device itself does not do any decision-making in regard to how the procedure is performed.

The purpose of this study is to measure if the Vertouch device helps the doctor perform the LP and EAI procedures more quickly and accurately. This study plans to include approximately 96 patients at 3 different hospital, with 32 of those patients being at MUSC.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
bulgarino@musc.edu

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



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