A Phase 1 interventional study of Botulinum toxin and Overstitch Endoscopic Suturing System in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-04-07.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 10 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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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 · Device: Overstitch Endoscopic Suturing System
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.
Also known as: Botox
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.
Change from baseline Bariatric Quality of Life (BQL) Questionaire
Time frame: baseline to 3 months
Change from baseline Three factor Eating Questionnaire (TFEQ-R21)
Time frame: baseline to 3 months
The record gives a start of Aug 2012, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum Toxins