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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
StomaphX No text entered.

Participant Flow:   Overall Study
    StomaphX
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
StomaphX Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic

Baseline Measures
   StomaphX 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.4  (6.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  92.9% 
Male      1   7.1% 
Pre-operative weight 
[Units: Kg]
Mean (Standard Deviation)
 119.5  (25.9) 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  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
e-mail: xinzhe.shi@ahs.ca


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