Clinical trial NCT02578836: Transoral Gastric Volume Reduction as an Intervention for Weight Management
Official title: Transoral Gastric Volume Reduction as an Intervention for Weight Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Keywords: Weight Loss
Overweight
Endoscopic treatment for obesity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Weight Loss
timeFrame: 12 months
Secondary outcomes:
measure: Emotional Wellbeing
timeFrame: 12 months
measure: Change in blood pressure
timeFrame: baseline to 12 months
measure: Change in cholesterol level
timeFrame: baseline to 12 months
measure: Change in glucose levels
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Clinical Research Building
state: Florida
Study officials:
affiliation: University of Miami
name: Roberto Fogel, MD
role: PRINCIPAL_INVESTIGATOR
References: