Gastric Restriction Using the EndoSurgical Operating System

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Device: Using the EOS for gastric restriction

• Registration Number: NCT01661608
• Lead Sponsor: USGI Medical

Brief Summary

The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Study First Posted: 2012-08-09
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
• Patient is >/= 20 yrs. of age and </= 60 yrs. of age
• Patient has a BMI of >/=30 and < 40
• Patient has history of obesity for >/= 2 yrs.
• Patient has had not significant weight change (<5% of total body weight) in last 6 months.
• Patient is a reasonable candidate for general anesthesia
• Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.

Exclusion Criteria

• Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
• Patient is not able to provide written informed consent
• Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
• Patient has diabetes secondary to a specific disease.
• Patient has history of inflammatory disease of GI tract
• Patient has diabetic retinopathy
• Patient has chronic pancreatic disease
• Patient ahs active peptic ulcer
• Patient has portal hypertension
• Patient has esophageal varices
• Patient has significant esophageal disease
• Patient has a history of any significant abdominal surgery
• Patient has a history of any bariatric or GERD surgical procedures
• Patient has a hiatal hernia > 2cm.
• Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
• Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
• Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
• Patient has cancer or life expectancy of < 2 yrs.
• Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
• Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
• Patient has a history of durg or alcohol abuse
• Patient has uncontrolled depression, psychosis, or eating disorder.
• Patient is non-ambulatory or has significant impairment of mobility.
• Patient has known hormonal or genetic cause for obesity.
• Patient is participating in another Registry and/or Study that could adversely affect this Registry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EOS	Using the EOS for gastric restriction	Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures

Primary Outcome Measures

Name	Time	Method
Clinical Evaluation in regards to Weight Loss	24 Months Post-op

Trial Locations

Locations (5)

Brigham & Womens; 🇺🇸 Boston, Massachusetts, United States

Mexico; 🇲🇽 Mexico City, Mexico

Bluegrass; 🇺🇸 Lexington, Kentucky, United States

SSL; 🇺🇸 New Orleans, Louisiana, United States

Presbyterian; 🇺🇸 Charlotte, North Carolina, United States