NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
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ClinicalTrials.gov Identifier: NCT01056913 |
Recruitment Status
:
Completed
First Posted
: January 26, 2010
Results First Posted
: January 29, 2014
Last Update Posted
: January 29, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse | Device: Compression Anastomosis Device Other: follow-up colonoscopy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Compression Anastomosis: Initial Clinical Experience With the ColonRingTM |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |
Arm | Intervention/treatment |
---|---|
NITI CAR27 (ColonRing) |
Device: Compression Anastomosis Device
Restoring intestinal continuity using the NITI CAR27 device
Other Names:
Other: follow-up colonoscopy
endoscopic exploration of anastomosis after complete healing
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- Anastomotic Leakage [ Time Frame: 4-8 weeks ]
- Clinical Relevant Stenosis [ Time Frame: six months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- benign and malign lesions of the colon and rectum
Exclusion Criteria:
- advanced peritonitis (putrid, feculent)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056913
Principal Investigator: | Friedrich Herbst, MD, FRCS | St John of God Hospital, Vienna |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bernhard Dauser, MD, MD, St John of God Hospital, Vienna |
ClinicalTrials.gov Identifier: | NCT01056913 History of Changes |
Other Study ID Numbers: |
CT2 |
First Posted: | January 26, 2010 Key Record Dates |
Results First Posted: | January 29, 2014 |
Last Update Posted: | January 29, 2014 |
Last Verified: | December 2013 |
Keywords provided by Bernhard Dauser, MD, St John of God Hospital, Vienna:
anastomotic leakage bleeding from the anastomotic region anastomotic stenosis |
Additional relevant MeSH terms:
Colonic Neoplasms Neoplasms Inflammatory Bowel Diseases Prolapse Diverticulitis Rectal Neoplasms Rectal Prolapse Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Pathological Conditions, Anatomical Intraabdominal Infections Infection Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Rectal Diseases Colonic Diseases Pelvic Organ Prolapse |