Transoral Gastric Volume Reduction as an Intervention for Weight Management

NCT02578836 | Withdrawn

• 1 other identifier: 20150200
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Obesity; Overweight; Weight Loss

Keywords

Weight Loss; Overweight; Endoscopic treatment for obesity

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  12 months

Secondary Outcomes (4)

• Emotional Wellbeing

  12 months

• Change in blood pressure

  baseline to 12 months

• Change in cholesterol level

  baseline to 12 months

• Change in glucose levels

  baseline to 12 months

Study Arms (1)

Fogel Gastroplasty

EXPERIMENTAL

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

Interventions

Fogel Gastroplasty PROCEDURE

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

Also known as: Endoscopic Vertical Gastroplasty

Fogel Gastroplasty

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients that are not willing to participate in the study
• Patients with history of Gastrointestinal tumors, Gastric Cancer, previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy, esophageal or gastric varices, or gastroparesis,
• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Clinical Research Building

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Roberto Fogel, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: August 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 31, 2017

Record last verified: 2017-05

Locations

US (1)