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Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

This study has been completed.
Sponsor:
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Juliane Bingener-Casey, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01080326
First received: March 2, 2010
Last updated: April 1, 2015
Last verified: April 2015
Results First Received: April 1, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Peptic Ulcer
Intervention: Device: Endoscopic Translumenal Omental Patch

  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
Subjects were enrolled between February 2010 and February 2012 at Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Endoscopic Translumenal Omental Patch

Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.

Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place.


Participant Flow:   Overall Study
    Endoscopic Translumenal Omental Patch  
STARTED     7  
COMPLETED     3  
NOT COMPLETED     4  
Patient deterioration prior to procedure                 3  
Surgeon decision                 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.
This includes only those participants for whom ulcer repair was attempted. Participants who were excluded in the operating room (OR) for previously unknown complications were not included.

Reporting Groups
  Description
Endoscopic Translumenal Omental Patch

Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.

Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place.


Baseline Measures
    Endoscopic Translumenal Omental Patch  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     2  
Gender  
[units: participants]
 
Female     2  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair   [ Time Frame: 2 days post-operation ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Juliane Bingener-Casey, M.D.
Organization: Mayo Clinic
phone: 507-538-9007
e-mail: BingenerCasey.Juliane@mayo.edu


Publications of Results:

Responsible Party: Juliane Bingener-Casey, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01080326     History of Changes
Other Study ID Numbers: 08-008389
ULIRR024150 ( Other Grant/Funding Number: NOSCAR )
Study First Received: March 2, 2010
Results First Received: April 1, 2015
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration