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

NCT ID: NCT00468416

Last Updated: 2007-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Compression Anastomosis Ring (CAR)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role collaborator

Kaplan Medical Center

OTHER

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Hagit Tulchinsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hagit Tulchinsky, M.D.

Role: CONTACT

[email protected]
+972-3-6973315 ext. 3315

Other Identifiers

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CLP-43-01-2

Identifier Type: -

Identifier Source: org_study_id