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Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00962650
First received: August 12, 2009
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Abdominal Adhesions
Intervention: Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance

  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
Study Initiation Date: 09 June 2009 (First Informed consent signed) Study Completion Date:03 May 2010 (Last subject last visit) Enrollment Location: The Ohio State University Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects provided informed consent to participate in the study, met protocol entry criteria, and had the study procedure attempted (ITT population).

Reporting Groups
  Description
Natural Orifice Transgastric Diagnostic Peritineoscopy Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.

Participant Flow:   Overall Study
    Natural Orifice Transgastric Diagnostic Peritineoscopy  
STARTED     10  
COMPLETED     8  
NOT COMPLETED     2  
Transgastric DP was not completed                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Natural Orifice Transgastric Diagnostic Peritineoscopy Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.

Baseline Measures
    Natural Orifice Transgastric Diagnostic Peritineoscopy  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  54.2  ± 9.76  
Gender  
[units: participants]
 		 
Female     9  
Male     1  
Region of Enrollment  
[units: participants]
 		 
United States     10  



  Outcome Measures

1.  Primary:   Completion of Diagnostic Peritineoscopy   [ Time Frame: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.


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
Ten male and female subjects indicated for Diagnostic Peritoneoscopy in advance of Roux-en Y Gastic Bypass procedure, who had a history of previous abdominal surgery, and met study Inclusion Criteria, were enrolled in the study.  


Results Point of Contact:  
Name/Title: Michael Schwiers, Principal Biostatistician
Organization: Ethicon Endo-Surgery, Inc.
phone: 513-337-1172
e-mail: mschwier@its.jnj.com


No publications provided


Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00962650     History of Changes
Other Study ID Numbers: CI-08-0007
Study First Received: August 12, 2009
Results First Received: December 20, 2010
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration