Clinical trial NCT01372501: Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
Official title: A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Morphic Medical Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 whether the the GI Endobarrier Liner can be reimplanted.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the % Excess Weight Loss at Week 52 or Last Assessment
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change in Absolute Weight Loss From Baseline to Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Dr. Alex P Escalona
Study officials:
affiliation: Pontificia Universidad Catolica de Chile, Santiago, Chile
name: Alex P Escalona, MD
role: PRINCIPAL_INVESTIGATOR
References: