Study for Short Term Weight Loss in Candidates for Bariatric Surgery

A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery

The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.

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 the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Dr. Nicholas Quezada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years and < 55 years - Male or Female
• BMI > 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or > 40 BMI <60 (with or without a co-morbid condition)
• History of failure with nonsurgical weight loss methods
• Candidates for Roux-en-Y gastric bypass
• Willing to comply with trial requirements
• Signed an ICF
• Post-menopausal women with surgical sterilization or following any treatment or family planning and not planning to become pregnant during the course of the investigation

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
• 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
• Active GERD
• Symptomatic kidney stones prior to implant
• 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
• Symptomatic gallstones prior to implant
• Symptomatic coronary artery disease or pulmonary dysfunction
• Known infection at the time of implant
• History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
• Pancreatitis or other serious organic conditions
• Requiring prescription anticoagulation therapy
• Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
• Having 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
• Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
• Having 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: 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 % Excess Weight Loss	Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as [(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)] * 100).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Type 2 Diabetic Status	Subjects who achieved HbA1c reduction of 0.5%	12 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Munoz R, Bambs C, Guzman S, Ibanez L, Gersin K. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012 Jun;255(6):1080-5. doi: 10.1097/SLA.0b013e31825498c4.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 25, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: obesity
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 08-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes