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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
Not Enrolling
Both
Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer

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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 UniversityDurham, North Carolina  27710