Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Study Overview
=================
Brief Summary
-----------------
Executive Summary Aims and Hypotheses of the Study: The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. The study will test a hypothesis that the StomaphyX procedure will be effective in promoting the loss of regained weight, reducing the risk for comorbidities and improving patients' quality of life. Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20 Inclusion Criteria: 18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss. Exclusion Criteria: Esophageal stricture, or any anatomic conditions that preclude passage of transoral endoluminal instruments, has another causal factor for weight regain other than stoma or pouch dilatation, portal hypertension, coagulation disorders or chronic use of anticoagulants, any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient. Intervention Treatment: Creation of multiple full-thickness plications within the gastric pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA) Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL, uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay

Official Title
-----------------
Phase II Study of Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Device: StomaphyX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years BMI 35 or greater with one or more comorbidities At least 2 years post-Roux-en-Y gastric bypass surgery At enrollment, has regained at least 15% of excess body weight loss Enlarged Stoma Diameter Enlarged gastric pouch Completed successful nutritional screening and compliant with nutritional programs Completed successful cardiopulmonary evaluation Patient willing to cooperate with follow-up assessment tests Signed informed consent Exclusion Criteria: Esophageal stricture or any anatomic conditions that preclude passage of transoral endoluminal instruments Has another causal factor for weight regain other than stoma or pouch dilatation such as non compliant with nutritional and exercise programs Portal hypertension Coagulation disorders or chronic use of anticoagulants Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StomaphyX Group<br>Primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Patients also demonstrate a weight regain of 15% of excess body weight loss. | Device: StomaphyX<br>* StomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome: Change in Body Weight | Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight. | At 6 months comparing to baseline weight | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enlarged gastric pouch and stoma, Post bariatric surgery