Multi-Center Pre-Bariatric Weight Loss Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469391
Recruitment Status : Completed
First Posted : May 4, 2007
Results First Posted : December 30, 2016
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):
GI Dynamics

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Device: GI Sleeve Implantable weight loss device (EndoBarrier)
Procedure: Sham Procedure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
GI Sleeve GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
Sham Control Sham Procedure followed by standard-of-care diet therapy

Participant Flow:   Overall Study
    GI Sleeve   Sham Control
STARTED   27   29 
Discontinued Prior to Procedure   2   3 
Unsuccessful Implant Procedure   4   0 
Adverse Event   8   0 
Lost to Follow up   0   1 
Patient Preference   0   1 
COMPLETED   13   24 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population: All subjects who did not withdraw before the procedure and device subjects who had a successful implant procedure

Reporting Groups
GI Sleeve

medical device that mimics gastric bypass mechanism for weight-loss

GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss

Sham Control Sham Procedure: Weight loss
Total Total of all reporting groups

Baseline Measures
   GI Sleeve   Sham Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   26   47 
[Units: Years]
Mean (Standard Deviation)
 44.8  (7.4)   42.7  (9.5)   43.7  (8.8) 
[Units: Participants]
Count of Participants
Female      15  71.4%      23  88.5%      38  80.9% 
Male      6  28.6%      3  11.5%      9  19.1% 
Region of Enrollment 
[Units: Participants]
United States   21   26   47 

  Outcome Measures

1.  Primary:   Percent Excess Weight Loss (%EWL) at Week 12   [ Time Frame: 3 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Clinical Affairs Manager
Organization: GI Dynamics, Inc.
phone: 781.357.3261

Responsible Party: GI Dynamics Identifier: NCT00469391     History of Changes
Other Study ID Numbers: 06-3
First Submitted: May 3, 2007
First Posted: May 4, 2007
Results First Submitted: November 1, 2016
Results First Posted: December 30, 2016
Last Update Posted: February 15, 2017