Radial Reload Open LAR Case Series

This study has been terminated.
Sponsor:
Collaborators:
Duke University
Providence Medical Research Center
University of South Florida
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01717014
First received: October 26, 2012
Last updated: February 13, 2015
Last verified: February 2015
  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
Low Anterior Resection
Proctosigmoid Resection
Rectal Cancer
Device: Covidien Radial Reload Stapler with Tri-Staple Technology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Staple Line [ Time Frame: Operative ] [ Designated as safety issue: No ]
    The surgeons ability to achieve a staple line at the desired level of the rectum.

  • Distal Margins [ Time Frame: Operative ] [ Designated as safety issue: No ]
    The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.


Secondary Outcome Measures:
  • Usability: Visibility [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    Visibility measured by surgeon usability questionnaire.

  • Usability: Access [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    Access measured by surgeon usability questionnaire

  • Usability: Manueverability [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate


Enrollment: 8
Study Start Date: May 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Covidien Radial Reload Stapler with Tri-Staple Technology
Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the 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 for the treatment of rectal cancer.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Washington
Providence Medical Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Medtronic - MITG
Duke University
Providence Medical Research Center
University of South Florida
  More Information

No publications provided

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01717014     History of Changes
Other Study ID Numbers: COVLARO0286
Study First Received: October 26, 2012
Results First Received: February 13, 2015
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic - MITG:
rectal cancer
stapler

ClinicalTrials.gov processed this record on June 30, 2015