Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

Obesity Clinical Trial

Official title:

A Pilot Trial of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372501
• Other study ID #: 09-3
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2011
• Last updated: February 13, 2016
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: GI Dynamics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Endobarrier Liner
Medical device placed endoscopically in the duodenum

Locations

Country	Name	City	State
Chile	Dr. Alex P Escalona	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
GI Dynamics

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the % Excess Weight Loss		52 Weeks	No
Secondary	Changes in Absolute Weight Loss and Percent (%) Body Weight Loss		Week 52	No