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

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

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CAMIS, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StomaphyX

Device

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

Alberta Health services

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Dec 3, 2009
Registry last updated: Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed