CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
Compression Anastomosis Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01056913
NCT01056913Phase 4Completed
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Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

St John of God Hospital, Vienna·interventional·Posted Jan 26, 2010·Updated Jan 29, 2014

In Brief

A Phase 4 clinical trial evaluating Compression Anastomosis Device and follow-up colonoscopy for Colonic Neoplasms and 4 related conditions. Completed, enrolled 62 participants.

Detailed Summary

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonic Neoplasms, Rectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Prolapse
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2010
Enrollment StartOct 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.4 years ago

Interventions

Compression Anastomosis Devicedevice

Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopyother

endoscopic exploration of anastomosis after complete healing