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

NCT01025076 | Completed Phase 2 Results

• 1 other identifier: Pro00008913
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Morbid Obesity

Keywords

Enlarged gastric pouch and stoma; Post bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

StomaphyX Group

EXPERIMENTAL

* 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

Interventions

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.

StomaphyX Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

CAMIS, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (23)

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MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Xinzhe Shi
• Organization: Royal Alexandra Hospital/CAMIS

xinzhe.shi@ahs.ca

7807356735

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc, MD, FRCSC

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 10, 2017
• Results First Posted: January 31, 2017

Record last verified: 2017-01

Locations

CA (1)