Transoral Gastric Volume Reduction as an Intervention for Weight Management

Withdrawn before enrolling · Not applicable

Conditions studied: Obesity, Overweight, Weight Loss

In brief

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)

Key facts

Study ID

NCT02578836

Run by

University of Miami

People needed

0

Starts

2017-08-01

Expected to finish

2018-11-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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