Transoral Gastric Volume Reduction as an Intervention for Weight Management
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | May 2016 |
| End Date: | November 2017 |
| Contact: | Roberto Fogel, MD |
| Email: | r.fogel@med.miami.edu |
| Phone: | 786-624-7858 |
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)
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)
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
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
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
We found this trial at
1
site
Miami, Florida 33136
Principal Investigator: Roberto Fogel, MD
Phone: 786-624-7858
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