Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study
Overview
- Phase
- Phase 1
- Intervention
- Botulinum toxin
- Conditions
- Obesity
- Sponsor
- Mayo Clinic
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change from baseline Bariatric Quality of Life (BQL) Questionaire
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Barham K. Abu Dayyeh, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
- •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
Arms & Interventions
Botulinum toxin at injection site
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.
Intervention: Botulinum toxin
Botulinum toxin at injection site
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.
Intervention: Overstitch Endoscopic Suturing System
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)(baseline to 3 months)