Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Endobarrier Liner

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Dr. Alex P Escalona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Device; All patients will be implanted with the Endobarrier Liner device	Device: Endobarrier Liner; Medical device placed endoscopically in the duodenum; Other Names: GI Sleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the % Excess Weight Loss at Week 52 or Last Assessment	Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2	52 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Absolute Weight Loss From Baseline to Week 52	Week 52

Collaborators and Investigators

• Sponsor: GI Dynamics
• Investigators: Principal Investigator: Alex P Escalona, MD, Pontificia Universidad Catolica de Chile, Santiago, Chile

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 09-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual data is available on site at Sponsor