drugset / Trial / NCT01682733

Endoscopic Gastric Reduction for Weight Management

NCT01682733

Phase 1 Completed 10 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-08
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin Protein / enzyme biologic 30 iu

Indications