Endoscopic Gastric Reduction for Weight Management

Mayo Clinic10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Botulinum toxinDRUG

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.

Overstitch Endoscopic Suturing SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Foundation

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change from baseline Bariatric Quality of Life (BQL) Questionaire

Time frame: baseline to 3 months

Secondary Outcomes

Change from baseline Three factor Eating Questionnaire (TFEQ-R21)

Time frame: baseline to 3 months

Data from ClinicalTrials.gov

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