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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056913
First Posted: January 26, 2010
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna
Results First Submitted: December 11, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Colonic Neoplasms
Rectal Neoplasms
Diverticulitis
Inflammatory Bowel Diseases
Rectal Prolapse
Interventions: Device: Compression Anastomosis Device
Other: follow-up colonoscopy

  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
No text entered.

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
NITI CAR27 (ColonRing)

Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing


Participant Flow:   Overall Study
    NITI CAR27 (ColonRing)
STARTED   62 
COMPLETED   62 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
NITI CAR27 (ColonRing)

Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing


Baseline Measures
   NITI CAR27 (ColonRing) 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Median (Full Range)
 67 
 (23 to 87) 
Gender 
[Units: Participants]
 
Female   30 
Male   32 


  Outcome Measures

1.  Primary:   Anastomotic Leakage   [ Time Frame: 4-8 weeks ]

2.  Secondary:   Clinical Relevant Stenosis   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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: Bernhard Dauser (MD)
Organization: St John of God Hospital Vienna
phone: +43121121 ext 5098
e-mail: bernhard.dauser@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT01056913     History of Changes
Other Study ID Numbers: CT2
First Submitted: January 24, 2010
First Posted: January 26, 2010
Results First Submitted: December 11, 2013
Results First Posted: January 29, 2014
Last Update Posted: January 29, 2014