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Study for Short Term Weight Loss in Candidates for Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00985491
First received: September 25, 2009
Last updated: August 3, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.

Condition Intervention Phase
Obesity
Device: Endobarrier Liner
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Assessment of % Excess Weight Loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Improvement in Type 2 Diabetic Status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects who achieved HbA1c reduction of 0.5%


Enrollment: 46
Study Start Date: October 2008
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985491

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT00985491     History of Changes
Other Study ID Numbers: 08-1 
Study First Received: September 25, 2009
Results First Received: February 13, 2016
Last Updated: August 3, 2016
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by GI Dynamics:
obesity

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 27, 2016