Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00911989
First received: May 31, 2009
Last updated: June 19, 2012
Last verified: June 2012
Results First Received: October 4, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Morbid Obesity
Intervention: Device: NOTES toolbox

  Participant Flow
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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
Transvaginal Sleeve Gastrectomy Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)

Participant Flow:   Overall Study
    Transvaginal Sleeve Gastrectomy  
STARTED     4  
COMPLETED     3  
NOT COMPLETED     1  
Adverse Event                 1  



  Baseline Characteristics
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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
Transvaginal Sleeve Gastrectomy Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)

Baseline Measures
    Transvaginal Sleeve Gastrectomy  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.3  ± 11.64  
Gender  
[units: participants]
 
Female     4  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures

1.  Primary:   Proportion of Procedures Completed With Successful Endoscopic Visualization.   [ Time Frame: Assessed intra-operatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: Ethicon-Endo Surgery
phone: 1.513.337.3079
e-mail: SHelsing@its.jnj.com


No publications provided


Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00911989     History of Changes
Other Study ID Numbers: CI-08-0008
Study First Received: May 31, 2009
Results First Received: October 4, 2011
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration