Endoscopic Gastric Reduction for Weight Management
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.
Drug: Botulinum toxin
Device: Overstitch Endoscopic Suturing System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study|
- Change from baseline Bariatric Quality of Life (BQL) Questionaire [ Time Frame: baseline to 3 months ] [ Designated as safety issue: Yes ]
- Change from baseline Three factor Eating Questionnaire (TFEQ-R21) [ Time Frame: baseline to 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Botulinum toxin at injection site
All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected.
Drug: Botulinum toxin
In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.
Other Name: BotoxDevice: Overstitch Endoscopic Suturing System
The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682733
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Barham K AbuDayyeh, MD||Mayo Clinic|