Endoscopic Gastric Reduction for Weight Management

Study Overview
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Brief Summary
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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.

Official Title
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Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study

Conditions
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Obesity

Intervention / Treatment
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* Drug: Botulinum toxin
* Device: Overstitch Endoscopic Suturing System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin at injection site<br>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. | Drug: Botulinum toxin<br>* 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.<br>* Other names: Botox;Device: Overstitch Endoscopic Suturing System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Bariatric Quality of Life (BQL) Questionaire |  | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Three factor Eating Questionnaire (TFEQ-R21) |  | baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight loss, Gastric reduction (volume), BMI 30-40