A Multicenter Study for Pre-Surgical Weight Loss

NCT00830440 | Completed Results

• 1 other identifier: 06-4
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery. It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue. The primary efficacy endpoint is:

• Assessment of the difference in % excess weight loss between the 2 groups Secondary endpoints are:
• Resolution or Improvement in type II Diabetic status as defined as:
• Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
• Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
• The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Total Weight Change From Baseline at 12 Weeks in kg

  12 weeks

Secondary Outcomes (2)

• % of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks

  12 weeks

• Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12

  Baseline to Week 12 of treatment

Study Arms (2)

EndoBarrier Device

EXPERIMENTAL

EndoBarrier Device and Diet \& Lifestyle Counseling

Device: EndoBarrier Device; Behavioral: Diet & Lifestyle Counseling

Control

ACTIVE COMPARATOR

Diet \& Lifestyle Counseling

Behavioral: Diet & Lifestyle Counseling

Interventions

EndoBarrier Device DEVICE

NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks

Also known as: EndoBarrier Gastrointestinal Liner

EndoBarrier Device

Diet & Lifestyle Counseling BEHAVIORAL

NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp

Control; EndoBarrier 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
• 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
• Patients willing to comply with study requirements
• Patients who have signed an informed consent form

You may not qualify if:

• Patients requiring prescription anticoagulation therapy
• Patients with iron deficiency and iron deficiency anemia
• Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
• Treatment represents an unreasonable risk to the patient
• Pancreatitis or other serious organic conditions
• Symptomatic coronary artery disease or pulmonary dysfunction
• Patients with known gallstones prior to implant
• Known infection at the time of implant
• Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Congenital or acquired anomalies of the GI tract such as atresias or stenoses
• Pregnant or has the intention of becoming pregnant in the next 12 months
• Unresolved alcohol or drug addiction
• HIV Positive patients
• Patients with hepatitis B or C
• Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (1)

University Hospital Maastricht

Maastricht, Netherlands

Location

Related Publications (1)

• Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43. doi: 10.1097/SLA.0b013e3181bdfbff.

  PMID: 19858703 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

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

kwoessner@gidynamics.com

781.357.3263

Study Officials

• Jan Willem Greve, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 17, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)