Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

NCT01372501 | Completed Phase 2 Results

• 1 other identifier: 09-3
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Absolute Weight Loss From Baseline to Week 52

  Week 52

Study Arms (1)

Experimental: Device

EXPERIMENTAL

All patients will be implanted with the Endobarrier Liner device

Device: Endobarrier Liner

Interventions

Endobarrier Liner DEVICE

Medical device placed endoscopically in the duodenum

Also known as: GI Sleeve

Experimental: Device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (1)

Dr. Alex P Escalona

Santiago, Chile

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: GI Dynamics, Inc.

pkeating@gidynamics.com

781.357.3261

Study Officials

• Alex P Escalona, MD

  Pontificia Universidad Catolica de Chile, Santiago, Chile

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 14, 2011
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: September 1, 2012
• Last Updated: February 15, 2017
• Results First Posted: March 11, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CL (1)