Phase 4
N=288
COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
Colorectal Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01091155 ↗Enrolled (actual)
288
Serious AEs
9.3%
Results posted
Oct 2013
Primary outcome: Primary: To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ColonRing (Colorectal anastomosis) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- novoGI
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month |
— | — |
| PRIMARY Device Related Leak Rate up to 30 Days Post op |
4 | — |
| SECONDARY Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. |
— | — |
Summary
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
Eligibility Criteria
Inclusion Criteria
- Subject is ≥ 18 years old.
- BMI < 34.
- Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion Criteria
- Subject has a known allergy to nickel.
- Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
- Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
- Subject's ASA (American Society of Anesthesiology) score 4 or 5.
- Subject has a concurrent or previous invasive pelvic malignancy.
- Subject has a systemic or incapacitating disease.
- Subject has extensive local disease in the pelvis.
- Subject requires more than one anastomosis during the surgery.
- Women who are known to be pregnant.
Data sourced from ClinicalTrials.gov (NCT01091155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.