Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
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|ClinicalTrials.gov Identifier: NCT01025076|
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : January 31, 2017
Last Update Posted : March 10, 2017
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
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.
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
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Device: StomaphyX||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||May 2012|
Experimental: StomaphyX Group
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.
- Primary Outcome: Change in Body Weight [ Time Frame: At 6 months comparing to baseline weight ]Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025076
|CAMIS, Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|