Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

NCT ID: NCT01372501

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Device

All patients will be implanted with the Endobarrier Liner device

Group Type: EXPERIMENTAL

Endobarrier Liner

Intervention Type: DEVICE

Medical device placed endoscopically in the duodenum

Interventions

Endobarrier Liner

Medical device placed endoscopically in the duodenum

Intervention Type: DEVICE

Other Intervention Names

GI Sleeve

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morphic Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex P Escalona, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile, Santiago, Chile

Locations

Dr. Alex P Escalona

Santiago, , Chile

Countries

Chile

Other Identifiers

09-3

Identifier Type: -

Identifier Source: org_study_id