Endoscopic Gastric Reduction for Weight Management
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/30/2013 |
| Start Date: | August 2012 |
| End Date: | January 2014 |
Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study
The proposed study is a prospective, pilot study to assess the feasibility of a novel
endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for
the primary treatment of obesity. The investigators aim to recruit ten subjects with a body
mass index between 30-40 for this study. Vertical sutures will be performed using the
endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum
toxin(approximately 30 units) will be injected around the sutures insertion sites in half of
the subjects randomly to slow down muscular grinding of the stomach to see if it improves
durability of the procedure.
Inclusion Criteria:
- Body Mass Index (BMI) between 30 and 40
- Age >18 and ≤50
- Stable weight for 3 months (within 5% of BMI)
- Normal basic labs (CBC, chemistry profile, creatinine)
- Negative pregnancy test for females >18 or ≤ 50
Exclusion Criteria:
- Diabetes
- Unstable coronary artery disease
- Heart failure
- Cardiac arrhythmia
- Cardiac valvular disease
- Obstructive of interstitial lung disease
- Females of child-bearing age >18 or ≤ 50 who are pregnant or lactating
- Mallampati score of 4
- ASA 3 or above
- Previous gastric surgery
- Ulcer disease
- Gastroparesis,
- > 5 cm Hiatal hernia
- Congenital anomalies of the GI tract
- Currently on or prescribed a medication known to affect weight within 3 months of
study entry.
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