Cochlear Implantation Quality of Life Measure Final Validation Save

Date Added
September 19th, 2017
PRO Number
Pro00070645
Researcher
Theodore Mcrackan
Keywords
Hearing, Surgery
Summary

In the first arm of this study (Pro00063109) we developed a list of questions that will be utilized in a new quality of life questionnaire for cochlear implant users. We developed a short and long form to be used in the clinical setting based on these questions. We would like to gather data from a large number of implant users in order to validate the long and short questionnaire forms. Both forms ask subjects how hearing loss and having a cochlear implant affects their life. Enrolled subjects will complete either the short or long form as well as the current gold standard quality of life measures twice one month apart greater than a year after receiving cochlear implantation.

Institution
MUSC
Recruitment Contact
Joshua Fabie
7178017021
fabie@musc.edu

Evaluation of the Clinical Performance of the Quantra System with the Quantra Surgical Cartridge in Adult Patients Undergoing Major Surgical Procedures Save

Date Added
June 27th, 2017
PRO Number
Pro00067522
Researcher
Charles Greenberg
Keywords
Surgery
Summary

This is a multicenter study of adult subjects undergoing major cardiac surgical procedures in which blood samples will be collected to test the performance of a research analyzer. Blood samples will be collected at four time points before, during, and after surgery. Approximately 50 subjects will be enrolled at MUSC.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
modzik@musc.edu

The OmniMax MMF System: A Cohort Study for Clinical Evaluation Save

Date Added
May 23rd, 2017
PRO Number
Pro00066533
Researcher
Martin Steed
Keywords
Dental, Surgery
Summary

The OmniMax MMF System is an FDA-cleared device consisting of metallic implants for the temporary stabilization of mandibular and maxillary bone during fracture healing. Mandibular and maxillary fixation (MMF) is achieved through application of fixation plates and locking screws to bone. Wire or elastics are then secured around hooks.

Institution
MUSC
Recruitment Contact
Amy Chamberlain
843-792-8352
chambeam@musc.edu

A Randomized, Single-Blind, Active-Controlled, Dose-Ranging Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing Total Knee Arthroplasty Save

Date Added
December 13th, 2016
PRO Number
Pro00060470
Researcher
Richard Friedman
Keywords
Surgery
Summary

The study is to see how safe and effective a drug called Liposomal tranexamic acid (DepoTXA) is in reducing postsurgical bleeding compared with intravenous (IV ? into a vein) Tranexamic Acid (TXA) in people undergoing total knee arthroplasty (TKA), otherwise known as knee replacement surgery. The study is an eight week study with a total of four visits with two of them follow-up telephone calls.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

The effect of early versus late urinary catheter removal on post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI) rates in patients with POUR risk factors receiving thoracic epidural analgesia (TEA) for post-operative thoracic surgery pain control Save

Date Added
November 15th, 2016
PRO Number
Pro00058458
Researcher
Michaella Prasad
Keywords
Bladder, Infectious Diseases, Pain, Spinal Cord, Surgery, Urinary
Summary

Patients scheduled for thoracic surgery will be identified as potential candidates and recruited by a research coordinator before surgery. Research subjects will be randomized to either early or late post-operative urinary catheter (a thin flexible tube placed into the bladder to drain urine) removal. Thoracic epidural analgesia (TEA), a thin tube placed near the spinal cord, will remain functioning after urinary catheter removal for the early group. The study group randomized to early catheter removal will have urinary catheters removed 24 hours after surgery is completed. Study subjects that are randomized to late removal of urinary catheter will have urinary catheters removed after TEA is discontinued as routine clinical care (usually 4-5 days). Determination of bladder urine volume will be made by sound wave examination (ultrasound) by appropriately-trained staff. Following indwelling urinary catheter removal, research subjects may receive a brief urine drain tube as standard clinical care. Laboratory urine analysis will be obtained from urine following removal of urinary catheter and assessed for urinary tract infection (UTI).

Institution
MUSC
Recruitment Contact
Bill Rawls
9196360725
rawlsw@musc.edu

BIOTRONIK, Inc. Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads Save

Date Added
October 25th, 2016
PRO Number
Pro00056102
Researcher
Sultan Siddique
Keywords
Cardiovascular, Heart, Surgery
Summary

The BIOTRONIK QP ExCELs study is a prospective, non-randomized, multi-center clinical investigation is to evaluate the safety and effectiveness of the BIOTRONIK Sentus over-the-wire (OTW) QP left ventricular (LV) lead. Male and female patients 18 years of age or older who have standard Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication may be eligible to participate in this study. This clinical protocol includes a single-arm, multi-center, prospective MultiPole Pacing (MPP) sub-study to demonstrate the MPP feature is effective by converting a percentage of CRT non-responders to responders.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Sultan Siddique, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Sultan Siddique
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

Grading Aortic Stenosis: A Comparison of Pre-Cardiopulmonary Bypass Transesophageal Echocardiography (TEE) to Preoperative Transthoracic Echocardiography (TTE) Save

Date Added
October 18th, 2016
PRO Number
Pro00059189
Researcher
George Whitener
Keywords
Heart, Surgery
Summary

This study is being done to evaluate if there is a significant difference in aortic stenosis grading on Transesophageal echo versus Transthoracic echo. Patients having aortic valve repair may be a candidate for this study.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

?Subclinical Detection of Harlequin Syndrome in Patients with Thoracic Epidurals? Save

Date Added
October 11th, 2016
PRO Number
Pro00056816
Researcher
Cory Furse
Keywords
Surgery
Summary

This study is being conducted to determine if there are temperature differences on each side of the face that may lead to an uncommon condition (Harlequin Syndrome) with patients who receive an epidural for pain control. This research is being done on patients having a Nuss procedure to correct pectus excavatum.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

Low vitamin D levels and outcomes after total knee and hip arthroplasty Save

Date Added
September 15th, 2016
PRO Number
Pro00053191
Researcher
Harry Demos
Keywords
Aging, Arthritis, Bone, Joint, Nutrition, Surgery, Vitamin D
Summary

Low vitamin d levels are common among patients undergoing orthopedic surgery. However, very little is known about how vitamin d affects outcomes in patients undergoing total joint replacement surgery. Our study will look at how common low vitamin d status is among patients undergoing total hip and total knee replacement surgery. We will also look at how vitamin d levels affect complication rates and hospital readmission rates.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST) Save

Date Added
August 16th, 2016
PRO Number
Pro00055080
Researcher
Katherine Morgan
Keywords
Diabetes, Digestive System, Insulin, Pancreas, Surgery, Transplant
Summary

The purpose of this research study is to learn more about the outcomes of total pancreatectomy with islet autotransplantation (TPIAT). Total pancreatectomy is the removal of the pancreas and islet autotransplantation is the placement of the insulin producing cells back into you to prevent diabetes. This study is looking to enroll patients who are scheduled to have a TPIAT surgery to treat pancreatitis (inflammation and scarring of the pancreas).

In addition to the routine care for pancreatitis and TPIAT surgery, participation in this study will involve completion of some brief surveys about the subject's health before TPIAT, at 6 months after TPIAT, and each year after the TPIAT surgery for 4 years, as well as a lab test conducted at each of the follow-up visits.

Institution
MUSC
Recruitment Contact
Christine Perez Rosa
843-792-0387
perezaro@musc.edu

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