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A Multicenter Study for Pre-Surgical Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Willem Greve, GI Dynamics
ClinicalTrials.gov Identifier:
NCT00830440
First received: January 26, 2009
Last updated: April 12, 2017
Last verified: April 2017
  Purpose

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.

Condition Intervention
Obesity Device: EndoBarrier Device Behavioral: Diet & Lifestyle Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss

Resource links provided by NLM:


Further study details as provided by Jan Willem Greve, GI Dynamics:

Primary Outcome Measures:
  • Total Weight Change From Baseline at 12 Weeks in kg [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • % 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.

  • Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12 [ Time Frame: Baseline to Week 12 of treatment ]

Enrollment: 43
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EndoBarrier Device
EndoBarrier Device and Diet & Lifestyle Counseling
Device: EndoBarrier Device
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks
Other Name: EndoBarrier Gastrointestinal Liner
Behavioral: Diet & Lifestyle Counseling
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp
Active Comparator: Control
Diet & Lifestyle Counseling
Behavioral: Diet & Lifestyle Counseling
NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830440

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
GI Dynamics
Investigators
Principal Investigator: Jan Willem Greve, MD Maastricht University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Willem Greve, Professor, GI Dynamics
ClinicalTrials.gov Identifier: NCT00830440     History of Changes
Other Study ID Numbers: 06-4
Study First Received: January 26, 2009
Results First Received: November 1, 2016
Last Updated: April 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 25, 2017