Radial Reload Laparoscopic LAR Case Series

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborators:
University Hospital Case Medical Center
Duke University
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01706822
First received: October 11, 2012
Last updated: March 17, 2015
Last verified: March 2015
  Purpose

To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.


Condition Intervention Phase
Colorectal Cancer
Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Phase 4

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 Laparoscopic Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met [ Time Frame: Operative ] [ Designated as safety issue: No ]
    The surgeon's ability to achieve a staple line at the desired level of the rectum.

  • The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met [ 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:
  • Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    1. Access measured by surgeon usability questionnaire.

  • Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    2. Visibility measured by surgeon usability questionnaire

  • Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree [ Time Frame: Operatively ] [ Designated as safety issue: No ]
    3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate


Enrollment: 8
Study Start Date: April 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 laparoscopic LAR or proctosigmoidectomy
Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Case series of patients arlaedy selected to undergo a laparoscopic LAR 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.
  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.
  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: NCT01706822

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Medtronic - MITG
University Hospital Case Medical Center
Duke University
Investigators
Principal Investigator: Conor Delaney, MD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01706822     History of Changes
Other Study ID Numbers: COVLARL0287
Study First Received: October 11, 2012
Results First Received: February 13, 2015
Last Updated: March 17, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2015