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Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Laparoscopic Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series


Phase 4
18 Years
85 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Laparoscopic 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
laparoscopically.

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:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Safety

Outcome Description:

Safety: evaluated through reported adverse events which include complications.

Outcome Time Frame:

30 Day follow-up

Safety Issue:

No

Principal Investigator

Conor Delaney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Case Medical Center

Authority:

United States: Institutional Review Board

Study ID:

COVLARL0287

NCT ID:

NCT01706822

Start Date:

April 2013

Completion Date:

December 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

University Hospitals Case Medical CenterCleveland, Ohio  44106