A Multicenter Study for Pre-Surgical Weight Loss

Obesity Clinical Trial

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

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate the safety and initial efficacy of the GI Sleeve™ device 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 GI Sleeve™ 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT00830440
• Study type: Interventional
• Source: GI Dynamics
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Completion date: September 2008