Back to resultsEvaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Compression Anastomosis Ring (CAR)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Tel Aviv Sourasky Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Functioning anastomosis and no occurrence of adverse events related to device use
Secondary Outcome Measures
Full Information
NCT ID
NCT00468416
First Posted
May 1, 2007
Last Updated
May 3, 2007
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Rabin Medical Center, Kaplan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00468416
Brief Title
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
Official Title
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Rabin Medical Center, Kaplan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Compression Anastomosis Ring (CAR)
Primary Outcome Measure Information:
Title
Functioning anastomosis and no occurrence of adverse events related to device use
Time Frame
During hospitalization and one month post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hagit Tulchinsky, M.D.
Phone
+972-3-6973315
Ext
3315
Email
hagitt@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagit Tulchinsky, M.D.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
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