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A Multicenter Study for Pre-Surgical Weight Loss

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

EndoBarrier Device

Diet & Lifestyle Counseling

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EndoBarrier Device

Control

Arm Description

EndoBarrier Device and Diet & Lifestyle Counseling

Diet & Lifestyle Counseling

Outcomes

Primary Outcome Measures

Total Weight Change From Baseline at 12 Weeks in kg

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00830440

First Posted

January 26, 2009

Last Updated

April 12, 2017

Sponsor

GI Dynamics

1. Study Identification

Unique Protocol Identification Number

NCT00830440

Brief Title

A Multicenter Study for Pre-Surgical Weight Loss

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

GI Dynamics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EndoBarrier Device

Arm Type

Experimental

Arm Description

EndoBarrier Device and Diet & Lifestyle Counseling

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Diet & Lifestyle Counseling

Intervention Type

Device

Intervention Name(s)

EndoBarrier Device

Other Intervention Name(s)

EndoBarrier Gastrointestinal Liner

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Diet & Lifestyle Counseling

Intervention Description

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

Primary Outcome Measure Information:

Title

Total Weight Change From Baseline at 12 Weeks in kg

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

Title

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

Time Frame

Baseline to Week 12 of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Willem Greve, MD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Maastricht

City

Maastricht

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19858703

Citation

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.

Results Reference

derived

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A Multicenter Study for Pre-Surgical Weight Loss

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