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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Functioning anastomosis and no occurrence of adverse events related to device use

Outcome Time Frame:

During hospitalization and one month post procedure

Principal Investigator

Hagit Tulchinsky, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel-Aviv Sourasky Medical Center

Authority:

Israel: Ministry of Health

Study ID:

CLP-43-01-2

NCT ID:

NCT00468416

Start Date:

February 2007

Completion Date:

February 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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