Study for Short Term Weight Loss in Candidates for Bariatric Surgery

GI Dynamics

Status and phase

Completed

Phase 2

Conditions

Obesity

Treatments

Device: Endobarrier Liner

Study type

Interventional

Funder types

Industry

Identifiers

NCT00985491

08-1

Details and patient eligibility

About

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

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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