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A Multicenter Study for Pre-Surgical Weight Loss

NCT00830440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-05-17

Study results available
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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

Interventions

DEVICE

EndoBarrier Device

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

BEHAVIORAL

Diet & Lifestyle Counseling

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

Sponsors & Collaborators

  • Morphic Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Jan Willem Greve, MD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-03-31
Completion
2008-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00830440 on ClinicalTrials.gov