Endoscopic Gastric Reduction for Weight Management

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Botulinum toxin; Device: Overstitch Endoscopic Suturing System

Study type: Interventional

Funder types: Other

Identifiers

NCT01682733

12-003195

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Botulinum toxin at injection site

Experimental group

Description:

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.

Treatment:

Device: Overstitch Endoscopic Suturing System

Drug: Botulinum toxin