Gastric Restriction Using the EndoSurgical Operating System

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Device: Using the EOS for gastric restriction

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EOS; Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures	Device: Using the EOS for gastric restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Evaluation in regards to Weight Loss	24 Months Post-op

Collaborators and Investigators

• Sponsor: USGI Medical
• Investigators: Principal Investigator: Michael J. Thomas, MD, FACS, SSL; Principal Investigator: Thomas Lavin, MD, SSL; Principal Investigator: David Voelinger, MD, Presbyterian; Principal Investigator: Peter Denk, MD, Bluegrass; Principal Investigator: Christopher Thompson, MD, Brigham & Womans; Principal Investigator: Santiago Horgan, MD, UCSD

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Estimate): August 9, 2012
• Last Update Submitted That Met QC Criteria: August 7, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Gastric Restriction
• Other Study ID Numbers: TPR41122