Clinical trial · Interventional
Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
NCT01056796CI-TRIAL-00005138unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is: Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR™ 27 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR™ 27
- description
- Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (\< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study.
- interventionNames
- Device: CAR™ 27
Primary outcomes (1)
- measure
- To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
- timeFrame
- Approx. 1 year
Secondary outcomes (1)
- measure
- Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is ≥ 18 years old. * Patient is scheduled for a non-emergency TME and low anterior resection (\< 10cm from the anal verge). * Patient has been radiated to the pelvic area 6-8 weeks prior to the study. * Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. Exclusion Criteria: * Patient has known allergy to nickel. * Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease. * Patients are participating in another clinical trial which may affect this study's outcomes. * Patient has been taking regular steroid medication. * Patient has contraindications to general anesthesia. * Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
References
Publications (0)
Data not yet available
No reference posted for this study.