Skip to main content
OpenTrials
Completed

NCT Number: NCT00830440

A Multicenter Study for Pre-Surgical Weight Loss

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Maastricht

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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
  • Previous GI surgery that could affect the ability to place the sleeve or the function of the implant.
  • Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
  • H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
  • Patients receiving weight loss medications such as Meridia and Xenical
  • Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Patients with gastroesophageal reflux disease (GERD)
  • Patients with a history of kidney stones
  • Participating in another ongoing investigational clinical trial

Treatment and study plan

EndoBarrier Device

Device

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

Other names: EndoBarrier Gastrointestinal Liner

Diet & Lifestyle Counseling

Behavioral

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

Primary outcomes

  1. Total Weight Change From Baseline at 12 Weeks in kg

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

    The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.

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

    Time frame: Baseline to Week 12 of treatment

Sponsors and collaborators

Lead sponsor

Morphic Medical Inc.

Industry

Registry information

Official study title

A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2009
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.