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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

October 26, 2012
October 26, 2012
November 2012
May 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low Anterior Resection
  • Proctosigmoid Resection
  • Rectal Cancer
Device: Covidien Radial Reload Stapler
Experimental: Covidien Radial Reload Stapler
Intervention: Device: Covidien Radial Reload Stapler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Jessica Chowaniec 203-821-4741 jessica.chowaniec@covidien.com
Contact: Jessica Carlson 203-821-4734 jessica.carlson@covidien.com
United States
 
NCT01717014
COVLARO0286
No
Covidien
Covidien
Not Provided
Not Provided
Covidien
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP