Gastric Restriction Using the EndoSurgical Operating System

NCT01661608 | Terminated DMC

• 1 other identifier: TPR41122
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Clinical Evaluation in regards to Weight Loss

  24 Months Post-op

Study Arms (1)

EOS

EXPERIMENTAL

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

Device: Using the EOS for gastric restriction

Interventions

Using the EOS for gastric restriction DEVICE

EOS

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (5)

Bluegrass

Lexington, Kentucky, United States

Location

SSL

New Orleans, Louisiana, United States

Location

Brigham & Womens

Boston, Massachusetts, United States

Location

Presbyterian

Charlotte, North Carolina, United States

Location

Mexico

Mexico City, Mexico

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

US (4); ME (1)