Bryan Clinical Research Center

AVANTI

Study Name: M21-341
Study Sponsor: Abbvie
Principal Investigator: Madeline Jones-Ryan, DO

Description: A Phase 2/3 multicenter, double blinded, randomized, dose-conversion, active control study examining the efficacy and safety of Armour Thyroid compared to synthetic T4 for the treatment of adults with primary hypothyroidism.

Status: Currently enrolling

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Beads Vs Vac

Study Name: A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds
Study Sponsor: US Department of Defense
Principal Investigator: Steve Shannon, MD

Description: The primary objective is to determine if the antibiotic bead pouch, compared to NPWT application, is more effective at reducing open tibia fracture complications.

Status: Currently enrolling

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HipAttack-2

Study Name: Hip Fracture Accelerated Care and Treatment Track
Study Sponsor: Population Health Research Institute
Principal Investigator: Steve Shannon, MD

Description: Millions of adults globally suffer a hip fracture annually. Approximately 20-25% of the patients who have a hip fracture have evidence of a heart injury when they present to the hospital. Patients with a hip fracture and myocardial injury have a much worse prognosis than patients with a hip fracture and no myocardial injury.  HIP-ATTACK-2 is a large international randomized controlled trial to assess the impact of accelerated medical clearance and surgery versus standard care in hip fracture patients who also have an acute myocardial injury when they present to the hospital. Patients who have suffered a hip fracture and have an elevated troponin level are eligible for the study.

Status: Currently enrolling

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JZP258 (XYWAV)

Study Name: A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Study Sponsor: Jazz Pharmaceuticals, Inc.
Principal Investigator: John Trapp, MD

Description: To evaluate the impact of switching from high-sodium oxybate to XYWAV on 24-hour ambulatory SBP for participants with narcolepsy

Status: Currently enrolling

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MIRA Surgical System Hysterectomy Study

Study Name: MIRA Surgical System for Umbrella Surgical Procedures: Minimally Invasive Benign Hysterectomy Clinical Study
Study Sponsor: Virtual Incision
Principal Investigator: Gregory Heidrick, MD

Description: A study to assess device performance and safety of the Miniaturized Robotic-Assisted Surgery System in benign hysterectomies.

Status: Currently enrolling

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VBI-S

Study Name: A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients with Septic Shock
Study Sponsor: Vivacelle Bio, Inc.
Principal Investigator: Radu Neamu, MD

Description: This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia (a decrease in the volume of circulating blood).

Status: Currently enrolling

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Vibrance-1

Study Name: ALKS 2680-201
Study Sponsor: Alkermes, Inc.
Principal Investigator: Kevin Reichmuth, MD

Description: The purpose of this study is to measure the safety, decrease in sleepiness, and decrease in sudden loss of muscle control (cataplexy) in subjects with narcolepsy type 1 (NT1) with ALKS 2680 tablets compared with placebo tablets.

Status: Currently enrolling

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xBar System

Study Name: A Safety and Effectiveness Prospective Blinded clinical study to validate xBAR system as a monitoring tool for anastomotic leaks detection
Study Sponsor: Exero Medical
Principal Investigator: Michael Jobst, MD

Description: xBar is a monitoring device intended to monitor subjects undergoing colorectal surgery with anastomosis to detect in a timely manner potential anastomotic leak. The study is intended to confirm the performance of the xBar system’s anastomotic leak detection monitoring tool in post operative colorectal surgical patients.

Status: Currently enrolling

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IMPACT2

Study Name: In-Home Study with MiniMed™ 780G Pump Automated Control in Type 2 - Evaluation of the AHCL System in Adults with Insulin-requiring Type 2 Diabetes
Study Sponsor: Medtronic
Principal Investigator: Shannon Wakeley, MD

Description: Type 2 diabetes mellitus, formerly known as non-insulin dependent diabetes and mature-onset diabetes, is characterized by a lack of insulin or insulin resistance In adults, type 2 diabetes accounts for 90–95% of all diagnosed cases of diabetes. The MiniMed 780G system is a closed loop insulin system. In addition to automatically adjusting the amount of insulin delivered based on sensor glucose readings, the MiniMed 780G insulin pump can also automatically deliver correction boluses as needed. The purpose of this study is to assess the safety and effectiveness of the MiniMed 780G system when used by adults with insulin-requiring type 2 diabetes. Patients with a clinical diagnosis of type 2 diabetes for 2 years or more, who are receiving 2 or more injections daily of long-acting insulin and rapid-acting analogs may be eligible for this study.

Status: Study completed - in follow up

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IONIS CORE 2: A Hypertriglyceridemia Study

Study Name: IONIS CORE 2: A Hypertriglyceridemia Study
Study Sponsor: Ionis Pharmaceuticals, Inc.
Principal Investigator: Aaron Ward, MD

Description: Hypertriglyceridemia is the most common form of dyslipidemia, affecting 77 million adults in the US.  This is a multi-center study to determine the effectiveness of Olezarsen (ISIS 678354) when administered subcutaneously to patients with severe hypertriglyceridemia. Patients with a fasting triglyceride level of 500mg/dL may be eligible to participate in this study.

Status: Completed enrollment - in follow up

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SAFFRON

Study Name: Sacral Fracture Fusion/Fixation for Rapid Rehabilitation: Randomized Controlled Trial
Study Sponsor: SI-Bone
Principal Investigator: Steve Shannon, MD

Description: Sacral fractures can result in substantial pain and disability and unfortunately, the incidence of these fractures is increasing. This study will evaluate the effectiveness and safety of surgery to treat sacral fractures and sacroiliac (SI) joint fusion vs non-surgical management. Participants will be randomized to surgery using the iFuse-TORQ implant or non-surgical treatment. Patients with stable sacral fragility or insufficiency fractures may be eligible for this study.

Status: Study Completed

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VIRTUAL INCISION

Study Name: Virtual Incision Robotically Assisted Surgical Device (VI RASD) for Umbrella Surgical Procedures: Minimally Invasive Right and Left Colectomy
Study Sponsor: Virtual Incision
Principal Investigator: John Trapp, MD

Description:The Virtual Incision Robotically Assisted Surgical Device (VI RASD) is a medical device used to perform abdominal surgery through one small incision in the abdominal wall. The mini robot affords the surgeon with situational awareness and precision positioning of the instrumentation to traverse the anatomy, access the surgical target, and excise it for evaluation. The VI RASD is designed to perform surgery with improved ergonomics, flexible surgical robot positioning, triangulation built into the instrumentation and camera setup, and the ability of the surgeon to visualize the target surgical area from multiple angles in the body. Patients presenting with the medical and/or surgical indication for right or left colon are eligible for the study. 

Status: Completed Enrollment - in follow up