Transoral Gastric Volume Reduction as an Intervention for Weight Management

Obesity Clinical Trial

Official title:

Transoral Gastric Volume Reduction as an Intervention for Weight Management

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02578836
• Other study ID #: 20150200
• Status: Withdrawn
• Phase: N/A
• First received: October 15, 2015
• Last updated: August 29, 2017
• Start date: August 1, 2017
• Est. completion date: November 2018

Study information

• Verified date: May 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami Clinical Research Building	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss		12 months
Secondary	Emotional Wellbeing	Measured by self administration of quality of life questionnaire SF-36	12 months
Secondary	Change in blood pressure		baseline to 12 months
Secondary	Change in cholesterol level		baseline to 12 months
Secondary	Change in glucose levels		baseline to 12 months