Current Surgery Research

EMERGENCY MEDICINE

IRB 22201 Comparison of the RightSpot pH Indicator & RightLevel pH Detector the Gold Standard of Radiographic Verification of Feeding Tube Placement & Gastrostomy Tube Replacement

Study Sponsor: Right BIOMETRICS Fluid Technologies

Purpose: The purpose of this study is to see if use of the RightSpot pH Indicator  and/or EZ-pH Indicator is as accurate in determining correct placement of feeding tubes and G-tube tubes as compared to the standard of care, which is getting an x-ray.

Principal Investigator: Timothy Havens, M.D.

Status: Active, Recruiting

Contact: Kathryn Lindsay, M.Ed., R.N., CCRN-K, CEN, CCRC, (314) 577-8460 or lindsayk@slu.edu

Full Study Details: https://clinicaltrials.gov/ct2/show/NCT01825564?term=rightspot%5C&rank=4

 

GENERAL SURGERY/SURGICAL ONCOLOGY

IRB 25108: Protocol AST-FP-005

A Multi-Center Study for the Collection of Surplus Surgical Tissues for Genomics, Proteomics and Biomarker Research (Fresh, Preserved, Blood)

Study Sponsor: Asterand US Acquisition Corp

Purpose: The purpose of this study is to collect high quality tissue samples and associated clinical data from consented study subjects.

Principal Investigator: Eddy Hsueh, M.D., FACS

Status:  Active, Recruiting

Contact: Kathryn Lindsay, M.Ed., R.N., CCRN-K, CEN, CCRC, (314) 577-8460, or lindsayk@slu.edu

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IRB 17322: Protocol 20140158

An ongoIng, 5-year post market study to track cliNical applicaTion, of DEcisionDx-Melanoma Gene expRession profile (GEP) Assay resulTs and the impact on patient outcomes and health Economics

Study Sponsor: Castle Biosciences, Inc.

Purpose: This study is being done to to collect information about how physicians are using the DecisionDx-CM results to design individual treatment plans.  It will also track outcomes of the cutaneous melanoma patients that receive DecisionDx-CM testing.

Principal Investigator: Eddy Hsueh, M.D., FACS

Status:  Active, Recruiting

Contact: Craig Dedert, B.S.N., R.N., CCRC, (314) 577-8461

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IRB 17927: Protocol 103A-301

A Multicenter, Double-Blind, Placebo-Controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-Resection Melanoma Patients with a High Risk of Recurrence

Study Sponsor: Polynoma, LLC

Purpose: The overall purpose of this research is to help determine how safe the investigational vaccine POL-103A is and how it works in humans who have melanoma.

Principal Investigator: Eddy Hsueh, M.D., FACS

Status:  Active, Recruiting

Contact: Kathryn Lindsay, M.Ed., R.N., CCRN-K, CEN, CCRC, (314) 577-8460, or lindsayk@slu.edu

Full Study Details:
http://clinicaltrials.gov/ct2/show/NCT01546571?term=polynoma&rank=|

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IRB 24622: Protocol 20120139

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

Study Sponsor: Amgen, Inc.

Purpose: The purpose of this observational registry study is to collect safety (ie, whether people have side effects or not) and survival (ie, whether people are alive or not) information on people who have previously received talimogene laherparepvec (formerly known as OncoVEXGM-CSF) in an Amgen or BioVex-sponsored clinical trial for the treatment of their melanoma cancer.

Principal Investigator: Eddy Hsueh, M.D., FACS

Status: Active, Enrolling by invitation only

Contact: Kathryn Lindsay, M.Ed., R.N., CCRN-K, CEN, CCRC, (314) 577-8460 or lindsayk@slu.edu

Full Study Details:
https://clinicaltrials.gov/ct2/show/NCT02173171?term=A+Registry+Study+to+Evaluate+the+Survival+and+Long-Term+Safety+of+Subjects+With+Melanoma+Who+Previously+Received+Talimogene+Laherparepvec&rank=1

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IRB 24519: Protocol 20110264

Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma

Study Sponsor: Amgen, Inc.

Purpose: The purpose of this study is to find out more about talimogene laherparepvec (formerly known as OncoVEXGM-CSF), in people with advanced melanoma when given in combination with another drug called ipilimumab.

Principal Investigator: Eddy Hsueh, M.D., FACS

Status: Active, Recruiting

Contact: Kathryn Lindsay, M.Ed., R.N., CCRN-K, CEN, CCRC, (314) 577-8460 or lindsayk@slu.edu

Full Study Details:
https://clinicaltrials.gov/ct2/show/NCT01740297?term=Talimogene+Laherparepvec&rank=2

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IRB 13909:

Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection versus Sentinel Multicenter Selective Lymphadenectomy for Melanoma Trial II: A Phase III Multicenter Lymphadenectomy Alone in Cutaneous Melanoma Patients with Molecular or Histopathological Evidence of Metastases in the Sentinel Node

Study Sponsor: John Wayne Cancer Institute

Purpose: The overall purpose of the research is to find out if melanoma can be treated by removing only a few lymph nodes (called “sentinel nodes”) from a lymph node basin (called a “sentinel node dissection”), or if all lymph nodes in a lymph basin must be removed (called a “complete lymph node dissection”).

Principal Investigator: Eddy Hsueh, MD, FACS

Status: Active, Closed to Recruitment

Contact: Pam Hunborg, B.S.N., R.N., CCRC, (314-268-5409) or hunborgp@slu.edu

Full Study Details

http://www.clinicaltrials.gov/ct2/show/NCT00297895?term=mslt&rank=6

 

VASCULAR SURGERY

IRB 16317:  Protocol Number: TAG 08-02

Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta

Study Sponsor: W. L. Gore & Associates, Inc.

Purpose: The overall purpose of this research is to determine the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta (the “study device”) as minimally invasive treatment alternative for traumatic aortic transaction patients.

Principal Investigator: Brian Peterson, M.D., FACS

Status: Active, Closed to recruitment

Contact: Craig Dedert, B.S.N., R.N., CCRC, (314) 577-8461

Full Study Details:

http://clinicaltrials.gov/ct2/show/NCT00917852?term=Treatment+of+Traumatic+Transection+of+the+Descending+Thoracic+Aorta&rank=1

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IRB 22813: Study Code D5135C00001

A Randomized, Double-Blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

Study Sponsor: AstraZeneca

Purpose: The overall purpose of this research is to test the hypothesis that ticagrelor monotherapy when compared with clopidogrel monotherapy will reduce the incidence of atherothrombotic ischemic events, as measured by the composite of CV death, MI, and ischemic stroke in patients with established PAD.

Principal Investigator: Catherine Wittgen, M.D., FACS

Status: Active, Closed to recruitment

Contact: Kathryn Lindsay, M.Ed., R.N., CCRN-K, CEN, CCRC, (314) 577-8460 or lindsayk@slu.edu

Full Study Details:

http://clinicaltrials.gov/ct2/show/NCT01732822?term=euclid&rank=1

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IRB 17347:  Protocol Number: CP-0011

LEOPARD Study: A Multicenter, Prospective, Randomized, Post-Market, Real-World Study to Assess Outcomes of Patients Treated with the AFX® System Compared to other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair

Study Sponsor: Endologix Inc.

Purpose: Objective of this post-market study is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation.

Principal Investigator: Emad Zakhary, MD

Status: Active, Open to recruitment

Contact: Craig Dedert, B.S.N., R.N., CCRC, (314) 577-8461

Full Study Details: http://clinicaltrials.gov/show/NCT02407457

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IRB 23951:  Protocol Number: TSP0149

Delivery of Dexamethasone to the Adventitia to Enhance Clinical Efficacy after Femoropopliteal Revascularization (DANCE)

Study Sponsor: Mercator Medsystems Inc.

Purpose: To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.

Principal Investigator: Donald Jacobs, MD

Status: Active, Recruiting

Contact: Craig Dedert, B.S.N., R.N., CCRC, (314) 577-8461

Full Study Details: https://clinicaltrials.gov/show/NCT01983449

 

REVISED 10/28/2015