A Multicenter Study for Pre-Surgical Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830440
• Other study ID #: 06-4
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: April 19, 2010
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2010
• Source: GI Dynamics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and initial efficacy of the GI Sleeve™ device 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 GI Sleeve™ 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 GERD

• Patients with a history of kidney stones

• Participating in another ongoing investigational clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• GI Sleeve™ (EndoBarrier)
Monthly visits

Other:
• Diet + Lifestyle Counseling
Monthly Visits

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
GI Dynamics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the difference in percent excess weight loss between the device group and a non-device, medically supervised diet control group		12-24 weeks	No
Secondary	The proportion of subjects achieving at least a 10% excess weight loss		12-24 weeks	No
Secondary	Resolution/improvement of Type 2 Diabetes defined as: Resolution: Subject is off diabetes medication, has normal fasting glucose Improvement: Normalizing fasting glucose and/or a reduction in dosing or frequency of diabetic medication		12-24 weeks	No