Gastric Restriction Using the EndoSurgical Operating System

NCT ID: NCT01661608

Last Updated: 2012-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-01-31

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.

Conditions

Obesity

Keywords

Gastric Restriction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

EOS

Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures

Group Type: EXPERIMENTAL

Using the EOS for gastric restriction

Intervention Type: DEVICE

Interventions

Using the EOS for gastric restriction

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USGI Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J. Thomas, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

SSL

Thomas Lavin, MD

Role: PRINCIPAL_INVESTIGATOR

SSL

David Voelinger, MD

Role: PRINCIPAL_INVESTIGATOR

Presbyterian

Peter Denk, MD

Role: PRINCIPAL_INVESTIGATOR

Bluegrass

Christopher Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham & Womans

Santiago Horgan, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

Bluegrass

Lexington, Kentucky, United States

SSL

New Orleans, Louisiana, United States

Brigham & Womens

Boston, Massachusetts, United States

Presbyterian

Charlotte, North Carolina, United States

Mexico

Mexico City, , Mexico

Countries

United States; Mexico

Other Identifiers

TPR41122

Identifier Type: -

Identifier Source: org_study_id