Transoral Gastric Volume Reduction as an Intervention for Weight Management

Not Applicable

Withdrawn

• Conditions: Weight Loss; Overweight; Obesity
• Interventions: Procedure: Fogel Gastroplasty

• Registration Number: NCT02578836
• Lead Sponsor: University of Miami

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)

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Status Verified: 2017-05
• Study Start: 2017-08-01
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-31
• Primary Completion: 2018-03
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fogel Gastroplasty	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

Primary Outcome Measures

Name	Time	Method
Weight Loss	12 months

Secondary Outcome Measures

Name	Time	Method
Emotional Wellbeing	12 months	Measured by self administration of quality of life questionnaire SF-36
Change in cholesterol level	baseline to 12 months
Change in glucose levels	baseline to 12 months
Change in blood pressure	baseline to 12 months

Trial Locations

Locations (1)

University of Miami Clinical Research Building; 🇺🇸 Miami, Florida, United States