Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00468416

Enrollment

Registered

2007-05-02

Start date

2007-02-28

Completion date

2008-02-29

Last updated

2007-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis

Interventions

DEVICECompression Anastomosis Ring (CAR)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient age over 18 years * Patient scheduled for colorectal cancer surgery * Patient is able to comprehend and sign the Informed Consent Form

Exclusion criteria

* Patient has known allergy to nickel * Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection * Patients who are participating in another trial * Patient on regular steroid medication * Patients who are undergoing a stoma * Patients with contraindications to general anesthesia * Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis * Patients after radiation * Patients who refuse consent

Design outcomes

Primary

Measure	Time frame
Functioning anastomosis and no occurrence of adverse events related to device use	During hospitalization and one month post procedure

Countries

Israel

Contacts

Primary ContactHagit Tulchinsky, M.D.

hagitt@tasmc.health.gov.il+972-3-6973315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026