Gastric Restriction Using the EndoSurgical Operating System

Obesity Clinical Trial

Official title:

Gastric Restriction Using the EndoSurgical Operating System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01661608
• Other study ID #: TPR41122
• Status: Terminated
• Phase: N/A
• First received: August 7, 2012
• Last updated: August 7, 2012
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2012
• Source: USGI Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Western Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Using the EOS for gastric restriction

Locations

Country	Name	City	State
Mexico	Mexico	Mexico City
United States	Brigham & Womens	Boston	Massachusetts
United States	Presbyterian	Charlotte	North Carolina
United States	Bluegrass	Lexington	Kentucky
United States	SSL	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
USGI Medical

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Evaluation in regards to Weight Loss		24 Months Post-op	No