NCT00830440

A Multicenter Study for Pre-Surgical Weight Loss

A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Morphic Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery. It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue. The primary efficacy endpoint is: * Assessment of the difference in % excess weight loss between the 2 groups Secondary endpoints are: * Resolution or Improvement in type II Diabetic status as defined as: * Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose) * Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication * The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	EndoBarrier Device	NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks
BEHAVIORAL	Diet & Lifestyle Counseling	NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-03-01
• Completion: 2008-09-01
• First posted: 2009-01-28
• Last updated: 2017-05-17
• Results posted: 2017-04-10

Locations

1 site across 1 country: Netherlands