A Phase 4 interventional study of Compression Anastomosis Device and follow-up colonoscopy in Colonic Neoplasms, Rectal Neoplasms and Diverticulitis, sponsored by St John of God Hospital, Vienna. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-01-29.
Sponsored by St John of God Hospital, Vienna · Phase 4, Interventional, and Treatment
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's enrollment of 62 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →St John of God Hospital, Vienna is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: Compression Anastomosis Device · Other: follow-up colonoscopy
Restoring intestinal continuity using the NITI CAR27 device
Also known as: ColonRing, BioDynamix Anastomosis
endoscopic exploration of anastomosis after complete healing
Anastomotic Leakage
Time frame: 4-8 weeks
Clinical Relevant Stenosis
Time frame: six months
| Milestone | NITI CAR27 (ColonRing) |
|---|---|
| Started | 62 |
| Completed | 62 |
| Not completed | 0 |
| participants | NITI CAR27 (ColonRing) |
|---|---|
| Anastomotic Leakage | 0 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NITI CAR27 (ColonRing) | — | 2/62 (3.2%) | 0/62 (0%) |
| Event | NITI CAR27 (ColonRing) |
|---|---|
| Anastomotic stenosisGastrointestinal disorders | 2/62 |
| Age, Continuous(years) | NITI CAR27 (ColonRing) |
|---|---|
| Median | 67 (23 to 87) |
| Sex: Female, Male(Participants) | NITI CAR27 (ColonRing) |
|---|---|
| Female | 30 |
| Male | 32 |
No study locations are listed for this record.
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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St John of God Hospital, Vienna