Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

GI Dynamics

Status and phase

Completed

Phase 2

Conditions

Obesity

Treatments

Device: Endobarrier Liner

Study type

Interventional

Funder types

Industry

Identifiers

NCT01372501

09-3

Details and patient eligibility

About

The purpose of this study is to determine whether the GI Endobarrier Liner can be reimplanted.

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 whether the the GI Endobarrier Liner can be reimplanted.

Enrollment

19 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years and < 55 years - Male or Female
Previously implanted with the EndoBarrier Gastrointestinal Liner
Subjects willing to comply with trial requirements
Subjects who have signed an informed consent form
Women who are post-menopausal, surgically sterile or on oral contraceptives for the duration of the study and who do not plan on becoming pregnant during the course of the trial.

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
Subjects 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.
Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)
Subjects with symptomatic kidney stones prior to implant
Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
Subjects with 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
Subjects with symptomatic gallstones prior to implant
Symptomatic coronary artery disease or pulmonary dysfunction
Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn)
History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
Pancreatitis or other serious organic conditions
Subjects requiring prescription anticoagulation therapy
Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
Subject 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.
Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure)
Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia