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NCT01091155 · ClinicalTrials.gov registry record · Phase 4
COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
A Phase 4 study of Colorectal Surgery, sponsored by novoGI.
- Completed
- Registry status
- Phase 4
- Development phase
- 288
- Enrollment target
- 13
- Study locations
NCT01091155: Completed Phase 4 study of Colorectal Surgery, sponsored by novoGI.
NCT01091155 is a Phase 4 study of Colorectal Surgery that has completed, run by novoGI. The registered enrollment target is 288 participants, roughly in line with the 294-participant average among 8 other Colorectal Surgery trials with a reported enrollment target. The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091155, a Phase 4 study of Colorectal Surgery, has completed, sponsored by novoGI.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 288 participants
- Enrollment target
- 13
- Study locations
Study Summary
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
Primary Outcome
Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.
Conditions Studied
Interventions
- DEVICE ColonRing (Colorectal anastomosis)
Study Locations (13)
Other
- KH Barmherzig Brueder - Vienna
- Ziekenhuis Oost Limburg - Genk
- University Hospital Gasthuisberg - Leuven
- Klinikum Neuperlach - Munich
- Bnai Zion Medical Center - Haifa
- Catharina Ziekenhuis - Eindhoven
California
- UCI Medical Center - Irvine
- University of Southern California Health Sciences Campus - Los Angeles
Missouri
- Lester E. Cox Medical Center - Springfield
- St. Louis University Hospital - St Louis
Florida
- FPMG Center for Colon & Rectal Surgery - Orlando
Georgia
- Southern Regional Medical Center - Riverdale
Illinois
- NorthShore University Health System - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT01091155 record still lists
NCT01091155 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 294-participant average among 8 other Colorectal Surgery trials with a reported enrollment target.
The record links to 1 condition, with Colorectal Surgery appearing as the primary indexed condition, and to 1 intervention - of which ColonRing (Colorectal anastomosis) is the first listed.
NCT01091155 lists 13 locations in 6 states (Other, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT01091155 about?
NCT01091155 is a clinical study titled "COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study". The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
What is the current status of trial NCT01091155?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 288 participants. The study started on 2010-03. Estimated completion is 2011-07.
What conditions does trial NCT01091155 study?
This clinical trial studies the following conditions: Colorectal Surgery.
What interventions are being tested in trial NCT01091155?
The interventions under investigation include: ColonRing (Colorectal anastomosis) (DEVICE).
Who is sponsoring clinical trial NCT01091155?
This trial is sponsored by novoGI, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01091155 being conducted?
This trial has 13 study locations across California, Florida, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Surgery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01091155's enrollment target sits among peer trials
288 3rd of 8 higher than 6 of 8 other Colorectal Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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