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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

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.
 
ClinicalTrials.gov Identifier: NCT01056913
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna

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
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NITI CAR27 (ColonRing)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 62
Completed 62
Not Completed 0
Arm/Group Title NITI CAR27 (ColonRing)
Hide Arm/Group Description

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

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

Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 62 participants
67
(23 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
30
  48.4%
Male
32
  51.6%
1.Primary Outcome
Title Anastomotic Leakage
Hide Description [Not Specified]
Time Frame 4-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NITI CAR27 (ColonRing)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Clinical Relevant Stenosis
Hide Description [Not Specified]
Time Frame six months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NITI CAR27 (ColonRing)
Hide Arm/Group Description

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

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

All-Cause Mortality
NITI CAR27 (ColonRing)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
NITI CAR27 (ColonRing)
Affected / at Risk (%) # Events
Total   2/62 (3.23%)    
Gastrointestinal disorders   
Anastomotic stenosis  [1]  2/62 (3.23%)  2
Indicates events were collected by systematic assessment
[1]
Symptomatic anastomotic stenosis resolved by endoscopic dilatation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NITI CAR27 (ColonRing)
Affected / at Risk (%) # Events
Total   0/62 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Bernhard Dauser (MD)
Organization: St John of God Hospital Vienna
Phone: +43121121 ext 5098
EMail: bernhard.dauser@gmail.com
Layout table for additonal information
Responsible Party: Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT01056913    
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