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Study for Short Term Weight Loss in Candidates for Bariatric Surgery

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Endobarrier Liner
Sponsored by
GI Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Nicholas Quezada

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

All patients will be implanted with the Endobarrier Liner device.

Outcomes

Primary Outcome Measures

Assessment of % Excess Weight Loss
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
Subjects who achieved HbA1c reduction of 0.5%

Full Information

First Posted
September 25, 2009
Last Updated
August 3, 2016
Sponsor
GI Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT00985491
Brief Title
Study for Short Term Weight Loss in Candidates for Bariatric Surgery
Official Title
A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI Dynamics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
All patients will be implanted with the Endobarrier Liner device.
Intervention Type
Device
Intervention Name(s)
Endobarrier Liner
Other Intervention Name(s)
GI Sleeve
Intervention Description
Medical device placed endoscopically in the duodenum
Primary Outcome Measure Information:
Title
Assessment of % Excess Weight Loss
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement in Type 2 Diabetic Status
Description
Subjects who achieved HbA1c reduction of 0.5%
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex P Escalona, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile, Santiago, Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Nicholas Quezada
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
22534421
Citation
Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Munoz R, Bambs C, Guzman S, Ibanez L, Gersin K. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012 Jun;255(6):1080-5. doi: 10.1097/SLA.0b013e31825498c4.
Results Reference
derived

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Study for Short Term Weight Loss in Candidates for Bariatric Surgery

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