Clinical Trials

                                                                                                                                                                 

Title:  Gatric Restriction Using the Endosurgical Operating System (EOS™).  Description:  This is a prospective, 1 year, multi-center registry evaluating the safety and effectiveness of a new endolumenal procedure for primary weight loss surgery in 100 patients over 5 centers across the US.  Sponsor:  USGI Medical, Inc of San Clemente, CA.  

Enrollment Status:  This study is currently CLOSED.

Title: Use of Endosurgical Operating System (EOS™) for Stoma and Pouch Reduction in Patients with weight regain after Roux-en-Y Gastric Bypass.  Description:  This is prospective, two-year, mult-center registry evaluating the safety and effectiveness of a new endolumenal procedure for revisional weight loss surgery in 150 patients over 10 centers across the US.  Sponsor:  USGI Medical, Inc of San Clemente, CA. 

Enrollment Status:  This study is currently CLOSED.

Title:  Lap-Band System Experience Trial (APEX™).  Description:  This is a five-year, multi-center, prospective trial evaluation of the new AP Lap-Band System for safety and effectiveness in 500 patients over 50 centers across the US.  Sponsor:  Allergan, Inc of Irvine, CA.  

Enrollment Status:  This study is currently CLOSED.

Title:  Helping Evaluate Reduction in Obesity (HERO)  Description This is prospective, five-year, multi-centered study of clinical outcomes and estimated healthcare resource expenditures associated with the treatment of obesity in patients utilizing the LAP-BAND™ AP Adjustable Gastric Banding System in approximately 60 sites across the U.S.  Sponsor Allergan, Inc of Irvine, CA. 

Enrollment Status This study is currently CLOSED.   

Title:  Use of Laparoscopic Adjustable Gastric Banding for the Treatment of Morbid Obesity in Adolescents.  Description:  This is a prospective, five-year trial evaluation of the AP Lap-Band System for effectiveness in 100 patients, evaluating weight loss, change in co-morbid conditions and improvement in quality of life for the adolescent between the ages of 14-17.  Sponsor:  Southeast Bariatrics of Charlotte, NC.

Enrollment Status:  This study is currently CLOSED.   

Title:  Sanctura XR for the treatment of Urinary Incontinence.  Description:  This is a multi-center, double-blind, placebo, controlled trial utilizing Sanctura XR 60 mg daily versus placebo in Obese females with a BMI of 35 or greater to treat overactive bladder syndrome.  Sponsor:  Allergan, Inc. of Irvine, CA.

Enrollment Status:  This study is currently CLOSED

Title:  Comparison of Meal Replacements versus Protein Supplements utilzing the PDCAAS Method in the Bariatric Patient.  Description:  This is single-site, four-week evaluation of meal replacement and protein supplement products for the bariatric patient undergoing the laparoscopic adjustable gastric band during the required four-week liquid diet in the pre-operative and post-operative phase.  Sponsor:  Southeast Bariatrics of Charlotte, NC. 

Enrollment Status:  This study is currently CLOSED.