---
title: Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
nct_id: NCT01056796
overall_status: UNKNOWN
phase: PHASE2
sponsor: Niti Medical Technologies Ltd.
study_type: INTERVENTIONAL
primary_condition: Colorectal Cancer
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01056796.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01056796"
ct_last_update_post_date: 2011-06-30
last_seen_at: "2026-05-12T07:00:11.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

**NCT ID:** [NCT01056796](https://clinicaltrials.gov/study/NCT01056796)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Niti Medical Technologies Ltd.
- **Collaborators:** University Hospital, Gasthuisberg
- **Conditions:** Colorectal Cancer
- **Start Date:** 2010-01
- **Completion Date:** 2012-05
- **CT.gov Last Update:** 2011-06-30

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **CAR™ 27** (EXPERIMENTAL) — 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.

## Interventions

- **CAR™ 27** (DEVICE) — Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients

## Primary Outcomes

- **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.** _(time frame: Approx. 1 year)_

## Secondary Outcomes

- **Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients** _(time frame: Approx. 1 year)_

## Locations (1)

- University Hospital, Gasthuisberg, Leuven, Belgium — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital, gasthuisberg|leuven||belgium` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01056796*  
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