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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

This study is not yet open for participant recruitment.
Verified October 2012 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01717014
First received: October 26, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.


Condition Intervention Phase
Low Anterior Resection
Proctosigmoid Resection
Rectal Cancer
 Device: Covidien Radial Reload Stapler
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Safety [ Time Frame: 30 Day follow-up ] [ Designated as safety issue: Yes ]
    Safety: evaluated through reported adverse events which include complications.

  • Feasibility [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    Assessed by a) the surgeon's ability to achieve a staple line at the desired level of the rectum, and b) by adequate distal margins (defined as >2 cm or >1 cm with clear histologic evaluation in the low rectum.


Secondary Outcome Measures:
  • Device Usability and Access as measured by Surgeon opinion [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    1. Access measured by surgeon usability questionnaire.
    2. Visibility measured by surgeon usability questionnaire.
    3. Maneuverability measured by surgeon usability questionnaire


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Covidien Radial Reload Stapler Device: Covidien Radial Reload Stapler

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717014

Contacts
Contact: Jessica Chowaniec 203-821-4741 jessica.chowaniec@covidien.com
Contact: Jessica Carlson 203-821-4734 jessica.carlson@covidien.com

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01717014     History of Changes
Other Study ID Numbers: COVLARO0286
Study First Received: October 26, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
rectal cancer
stapler

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 18, 2013