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Radial Reload Laparoscopic Case Series

This study is currently recruiting participants.
Verified May 2013 by Covidien
Sponsor:
Collaborators:
University Hospital Case Medical Center
Duke University
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01706822
First received: October 11, 2012
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

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: No ]
    Safety: evaluated through reported adverse events which include complications.

  • Staple Line & Distal Margins [ 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:
  • Usability [ 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: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Covidien Radial Reload Stapler with Tri-Staple Technology
Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
 Device: Covidien Radial Reload Stapler with Tri-Staple Technology
Case series of patients already selected to undergo a laparoscopic 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
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing laparoscopic LAR or proctosigmoidectomy for treatment of rectal cancer.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706822

Contacts
Contact: Jessica Carlson 203-821-4734

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Conor Delaney, MD            
Sponsors and Collaborators
Covidien
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: Covidien
ClinicalTrials.gov Identifier: NCT01706822     History of Changes
Other Study ID Numbers: COVLARL0287
Study First Received: October 11, 2012
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013