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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
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Shahzeer Karmali, University of Alberta

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Morbid Obesity
Intervention Device: StomaphyX
Enrollment 14

Recruitment Details  
Pre-assignment Details  
Arm/Group Title StomaphX
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title StomaphX
Hide Arm/Group Description Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
46.4  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
13
  92.9%
Male
1
   7.1%
Pre-operative weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 14 participants
119.5  (25.9)
1.Primary Outcome
Title Primary Outcome: Change in Body Weight
Hide Description Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.
Time Frame At 6 months comparing to baseline weight
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title StomaphX
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: kg
9.6  (7.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title StomaphX
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
StomaphX
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
StomaphX
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
StomaphX
Affected / at Risk (%) # Events
Total   3/14 (21.43%)    
Surgical and medical procedures   
headache  2/14 (14.29%)  2
low back pain  1/14 (7.14%)  1
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
Publications:
Responsible Party: Shahzeer Karmali, University of Alberta
ClinicalTrials.gov Identifier: NCT01025076     History of Changes
Other Study ID Numbers: Pro00008913
First Submitted: December 2, 2009
First Posted: December 3, 2009
Results First Submitted: December 6, 2016
Results First Posted: January 31, 2017
Last Update Posted: March 10, 2017