Transoral Gastric Volume Reduction as an Intervention for Weight Management

August 29, 2017 updated by: Roberto Fogel, University of Miami

This study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). The purpose of the study is to:

  • Document that weight loss occurs (12 months)
  • Determine if it alters general wellbeing (emotionally and physically)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective study evaluating the percentage of weight loss in patients that have undergo the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). Fogel's Gastroplasty is a procedure where The subject will be placed under general anesthesia in accordance with the Institution's standard practice. The procedure will last approximately 1-2 hours. Following induction of anesthesia, the overtube will be placed, a gastroscope will be inserted to examine esophageal and gastric anatomy and re-confirm there are no anatomical contraindications to the procedure. The gastroscope will also be used to record images of the stomach prior to insertion of the OverStitch. Once the examination is complete the gastroscope will be removed. The OverStitch system will then be inserted orally to the per-operative site. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch. Once complete, the OverStitch system will be removed and a standard gastroscope will be inserted to record post procedure endoscopic images.

Anthropometric measurements as Weight, Height, BMI and Waist Circumference will be collected at Baseline, 3, 6 and 12 months after procedure

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Clinical Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
  2. Subject has a BMI between 28 and 34.9
  3. Subject is willing to complete all follow-up visits after procedure ( 3, 6 and 12 months)

Exclusion Criteria:

  1. Patients that are not willing to participate in the study
  2. Patients with history of Gastrointestinal tumors, Gastric Cancer, previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy, esophageal or gastric varices, or gastroparesis,
  3. Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility or Hiatal Hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fogel Gastroplasty
The subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition
Procedure: Fogel Gastroplasty
The subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition
Other Names:
  • Endoscopic Vertical Gastroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Wellbeing
Time Frame: 12 months
Measured by self administration of quality of life questionnaire SF-36
12 months
Change in blood pressure
Time Frame: baseline to 12 months
baseline to 12 months
Change in cholesterol level
Time Frame: baseline to 12 months
baseline to 12 months
Change in glucose levels
Time Frame: baseline to 12 months
baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Roberto Fogel, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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