Endoscopic Gastric Reduction for Weight Management
Completed · Phase 1
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT01682733
- Run by
- Mayo Clinic
- People needed
- 10
- Starts
- 2012-08-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-04-07
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mayo Foundation — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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