Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness.

Date Added
September 23rd, 2024
PRO Number
Pro00136394
Researcher
Mark Miller

List of Studies

Keywords
Bone, Children's Health, Surgery
Summary

The primary objective of this study is to demonstrate the safety and effective use of Stryker's PEEK Customized Implants in patients receiving craniofacial (head and facial) surgery. Other objectives include using a CT scan to assist surgeons with providing a solution to complex and simple reconstruction challenges and reducing them to a single or two-stage procedure, thereby minimizing the overall surgery time and limiting the number of surgeries. Patient questionnaires and health information will be used during the study to demonstrate the safety and effectiveness of the implants. We will be enrolling ages 4 - 75 years old.

Institution
MUSC
Recruitment Contact
Monicagail Reyes
843-792-7333
reyesmo@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

Date Added
August 7th, 2024
PRO Number
Pro00137409
Researcher
Harold Szerlip

List of Studies

Keywords
Coronary Artery Disease, Surgery
Summary

Up to 67% of patients undergoing heart surgery may experience complications after surgery. These complications may include longer stay in the intensive care unit (ICU), more time on a ventilator (also known as a breathing machine), longer overall stay in the hospital, having to return to the hospital soon after being discharged, and even death.

This research study is being performed to see whether RBT-1, an investigational new drug, can reduce complications after heart surgery

In this research study, you will have a 50% chance of being assigned to receive RBT-1 and a 50% chance of being assigned to receive placebo.

If you decide to participate, you will receive a single intravenous (IV) infusion (an infusion into your vein) of either: 1) RBT-1 at a dose level of 45 mg SnPP/240 mg FeS or 2) placebo in the form of normal saline (salt water solution). You cannot choose whether you are given RBT-1 or placebo.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
8437928166
pregulma@musc.edu

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Date Added
July 1st, 2024
PRO Number
Pro00136775
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck, Men's Health, Surgery, Women's Health
Summary

This phase II/III study purpose is to see if neck and shoulder function and pain are better after sentinel lymph node (SLN) biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. If decided to participate in this study participants will go through a pre-treatment period to determine if they are eligible for the study including a PET/CT scan to determine if their cancer has spread. They will also receive a quality of life questionnaire to determine their physical well-being. Participants will complete these questionnaires 5 times: before surgery; at 3 weeks after surgery; and at 3, 6 and 12 months after surgery. If their cancer has not spread participants will be randomized to receive SLN or the SOC Elective Neck Dissection (END) to remove their cancer/lymph nodes during the treatment period. Following treatment, participants will enter the follow-up period and the study doctor will continue to follow participates condition and watch for side effects of the surgery. Participants will visit in the clinic at 3 weeks after surgery, then every 3 months for the first year, then every 4 months for the second year, then every 6 months for the third year, then yearly for their lifetime. The study duration for the phase II portion is about 37 months (~3.1 years) and around 132 months (11 years) for the phase III portion. The main risk associated with this study are leakage of lymph fluid called "chyle" into the neck, nerve injury and shoulder movement problems, swallowing difficulty, lung infection, and bleeding. There is evidence that the SLN biopsy technique causes less shoulder and neck movement problems and pain, and is effective in removing your cancer. It is not possible to know now if the SLN biopsy approach will be as good at extending your time without disease compared to the usual END approach. This study will help the study doctors learn things that will help people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation

Date Added
April 16th, 2024
PRO Number
Pro00131410
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Aging, Brain, Movement Disorders, Parkinsons, Surgery
Summary

For this study, we are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS study participants will undergo a MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta

Date Added
April 11th, 2024
PRO Number
Pro00135230
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular, Surgery, Vascular
Summary

Assess the safety and effectiveness of the ASG device in
the treatment of lesions involving the ascending aorta and
aortic arch.

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

Clinical Safety and Performance of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Date Added
April 9th, 2024
PRO Number
Pro00135936
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart, Surgery
Summary

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the VDyne Transcatheter Tricuspid Replacement System will be used to treat the tricuspid regurgitation. The VDyne Transcatheter Tricsupid Replacement System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study all eligible participants will be treated with the device.

Participation in this study will last about 5 years and involve up to 13 visits. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

There are risks associated with this study including potential risks with the device, implant procedure and study related procedures. There is also the risk of loss of confidentiality. The study may or may not benefit you but the information learned may benefit others with this condition in the future.

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

Quantification of Factors Affecting Vaginal Length in Robotic Sacrocolpopexy

Date Added
March 19th, 2024
PRO Number
Pro00134575
Researcher
Faith Dunn

List of Studies

Keywords
Surgery, Women's Health
Summary

The purpose of this study is to better understand how surgical factors affect the length of the vagina after pelvic surgery. This will be accomplished by measuring the length of the vagina during routine surgical steps as well as at the postoperative visit. This information will be used to help continue improving pelvic surgical technique.

Institution
MUSC
Recruitment Contact
Faith Dunn
8437922300
dunnfa@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

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

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu



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