Endoscopic Gastric Reduction for Weight Management

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Botulinum toxin; Device: Overstitch Endoscopic Suturing System

• Registration Number: NCT01682733
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum toxin at injection site	Botulinum toxin	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.
Botulinum toxin at injection site	Overstitch Endoscopic Suturing System	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Bariatric Quality of Life (BQL) Questionaire	baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline Three factor Eating Questionnaire (TFEQ-R21)	baseline to 3 months

Trial Locations

Locations (1)

Mayo Foundation; 🇺🇸 Rochester, Minnesota, United States