Evaluating Safety and Feasibility of the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
Phase 4
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
Both
Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
Trial Information
Evaluating Safety and Feasibility of the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
Inclusion Criteria:
1. The subject is able to understand and sign Informed Consent Form.
2. The subject is between 18-85 years of age.
3. The subject is anticipated to undergo a resection of the rectum with anastomosis
below the peritoneal reflection.
4. The subject is anticipated to undergo mobilization and stapling of the rectum through
an open incision.
Exclusion Criteria:
1. Any female patient, who is pregnant, suspected pregnant, or nursing.
2. The participant is unable or unwilling to comply with the study requirements,
follow-up schedule.
3. The participant has co-morbidities which, in the opinion of the investigator, will
not be appropriate for the study.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Outcome Description:
Safety: evaluated through reported adverse events which include complications.
Outcome Time Frame:
30 Day follow-up
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
COVLARO0286
NCT ID:
NCT01717014
Start Date:
November 2012
Completion Date:
May 2013
Related Keywords:
- Low Anterior Resection
- Proctosigmoid Resection
- Rectal Cancer
- rectal cancer
- stapler
- Rectal Neoplasms
Name | Location |
|---|---|
| Duke University | Durham, North Carolina 27710 |
