Clincosm LogoSign in Get a demo

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

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT01025076
Collaborator
Alberta Health services (Other)
14
Enrollment
1
Location
1
Arm
38.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: StomaphyX
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Feb 1, 2009
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: StomaphyX Group

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
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.

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome: Change in Body Weight [At 6 months comparing to baseline weight]

    Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CAMIS, Royal Alexandra Hospital Edmonton Alberta Canada T5H 3V9

Sponsors and Collaborators

  • University of Alberta
  • Alberta Health services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shahzeer Karmali, BSc, MD, FRCSC, University of Alberta
ClinicalTrials.gov Identifier:
NCT01025076
Other Study ID Numbers:
  • Pro00008913
First Posted:
Dec 3, 2009
Last Update Posted:
Mar 10, 2017
Last Verified:
Jan 1, 2017
Keywords provided by Shahzeer Karmali, BSc, MD, FRCSC, University of Alberta
Enlarged gastric pouch and stoma
Post bariatric surgery
Additional relevant MeSH terms:
Obesity, Morbid

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title StomaphX
Arm/Group Description
Period Title: Overall Study
STARTED 14
COMPLETED 14
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title StomaphX
Arm/Group Description Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
Overall Participants 14
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
46.4
(6.7)
Sex: Female, Male (Count of Participants)
Female
13
92.9%
Male
1
7.1%
Pre-operative weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]
119.5
(25.9)

Outcome Measures

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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title StomaphX
Arm/Group Description
Measure Participants 14
Mean (Standard Deviation) [kg]
9.6
(7.9)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title StomaphX
Arm/Group Description
All Cause Mortality
StomaphX
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
StomaphX
Affected / at Risk (%) # Events
Total 0/14 (0%)
Other (Not Including Serious) Adverse Events
StomaphX
Affected / at Risk (%) # Events
Total 3/14 (21.4%)
Surgical and medical procedures
headache 2/14 (14.3%) 2
low back pain 1/14 (7.1%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Xinzhe Shi
Organization Royal Alexandra Hospital/CAMIS
Phone 7807356735
Email xinzhe.shi@ahs.ca
Responsible Party:
Shahzeer Karmali, BSc, MD, FRCSC, University of Alberta
ClinicalTrials.gov Identifier:
NCT01025076
Other Study ID Numbers:
  • Pro00008913
First Posted:
Dec 3, 2009
Last Update Posted:
Mar 10, 2017
Last Verified:
Jan 1, 2017