Radial Reload Open LAR Case Series

February 13, 2015 updated by: Medtronic - MITG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • University Of South Florida
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staple Line
Time Frame: Operative
The surgeons ability to achieve a staple line at the desired level of the rectum.
Operative
Distal Margins
Time Frame: Operative
The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.
Operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability: Visibility
Time Frame: Operatively
Visibility measured by surgeon usability questionnaire.
Operatively
Usability: Access
Time Frame: Operatively
Access measured by surgeon usability questionnaire
Operatively
Usability: Manueverability
Time Frame: Operatively
Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate
Operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Collaborators

University of South Florida
Duke University
Providence Medical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 13, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVLARO0286

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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