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Study for Short Term Weight Loss in Candidates for Bariatric Surgery

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: NCT00985491
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : August 3, 2016
Last Update Posted : September 15, 2016
Information provided by (Responsible Party):
GI Dynamics

Brief Summary:
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.

Condition or disease Intervention/treatment Phase
Obesity Device: Endobarrier Liner Phase 2

Detailed Description:
Patients with obesity are at significantly greater risk of developing significant co-morbid complications, and are associated with an increased risk in all-cause mortality. The GI Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It is a minimally invasive endoscopic procedure, which may allow patients to recover faster with less morbidity and mortality. This study is investigating the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery
Study Start Date : October 2008
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Device
All patients will be implanted with the Endobarrier Liner device.
Device: Endobarrier Liner
Medical device placed endoscopically in the duodenum
Other Name: GI Sleeve

Primary Outcome Measures :
  1. Assessment of % Excess Weight Loss [ Time Frame: 12 months ]
    Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as [(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)] * 100).

Secondary Outcome Measures :
  1. Improvement in Type 2 Diabetic Status [ Time Frame: 12 months ]
    Subjects who achieved HbA1c reduction of 0.5%

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years and < 55 years - Male or Female
  • BMI > 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or > 40 BMI <60 (with or without a co-morbid condition)
  • History of failure with nonsurgical weight loss methods
  • Candidates for Roux-en-Y gastric bypass
  • Willing to comply with trial requirements
  • Signed an ICF
  • Post-menopausal women with surgical sterilization or following any treatment or family planning and not planning to become pregnant during the course of the investigation

Exclusion Criteria:

  • Treatment represents an unreasonable risk to the subject
  • Pregnant or have intention of becoming pregnant for the duration of the trial
  • Unresolved alcohol or drug addiction
  • Receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
  • Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Liner or the function of the implant
  • Active GERD
  • Symptomatic kidney stones prior to implant
  • Iron deficiency and/or iron deficiency anemia
  • History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
  • Symptomatic gallstones prior to implant
  • Symptomatic coronary artery disease or pulmonary dysfunction
  • Known infection at the time of implant
  • History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
  • Pancreatitis or other serious organic conditions
  • Requiring prescription anticoagulation therapy
  • Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
  • Having or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Participating in another ongoing investigational clinical trial
  • Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial
  • Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
  • Having or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00985491

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Dr. Nicholas Quezada
Santiago, Chile
Sponsors and Collaborators
GI Dynamics
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Principal Investigator: Alex P Escalona, MD Pontificia Universidad Catolica de Chile, Santiago, Chile

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GI Dynamics Identifier: NCT00985491    
Other Study ID Numbers: 08-1
First Posted: September 28, 2009    Key Record Dates
Results First Posted: August 3, 2016
Last Update Posted: September 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by GI Dynamics:
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes