Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Intervention: StomaphyX
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Enlarged gastric pouch and stoma; Post bariatric surgery

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
    

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