Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

October 26, 2012
February 13, 2015
May 2013
November 2013   (final data collection date for primary outcome measure)
  • 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.
  • 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.
Complete list of historical versions of study NCT01717014 on ClinicalTrials.gov Archive Site
  • 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
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
Not Provided
Not Provided
 
Radial Reload Open LAR Case Series
Evaluating 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
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low Anterior Resection
  • Proctosigmoid Resection
  • Rectal Cancer
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
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
Intervention: Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
November 2013
November 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 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.
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01717014
COVLARO0286
No
Not Provided
Not Provided
Medtronic - MITG
Medtronic - MITG
  • Duke University
  • Providence Medical Research Center
  • University of South Florida
Not Provided
Medtronic - MITG
February 2015

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