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Radial Reload Open LAR Case Series

Primary Purpose

Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Covidien Radial Reload Stapler with Tri-Staple Technology
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Anterior Resection focused on measuring rectal cancer, stapler

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Florida
  • Duke University
  • Providence Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Covidien Radial Reload Stapler with Tri-Staple Technology

Arm Description

Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Usability: Visibility
Visibility measured by surgeon usability questionnaire.
Usability: Access
Access measured by surgeon usability questionnaire
Usability: Manueverability
Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate

Full Information

First Posted
October 26, 2012
Last Updated
February 13, 2015
Sponsor
Medtronic - MITG
Collaborators
Duke University, Providence Medical Research Center, University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01717014
Brief Title
Radial Reload Open LAR Case Series
Official Title
Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
Collaborators
Duke University, Providence Medical Research Center, University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
Keywords
rectal cancer, stapler

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Covidien Radial Reload Stapler with Tri-Staple Technology
Arm Type
Experimental
Arm Description
Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Intervention Type
Device
Intervention Name(s)
Covidien Radial Reload Stapler with Tri-Staple Technology
Intervention Description
Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler
Primary Outcome Measure Information:
Title
Staple Line
Description
The surgeons ability to achieve a staple line at the desired level of the rectum.
Time Frame
Operative
Title
Distal Margins
Description
The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.
Time Frame
Operative
Secondary Outcome Measure Information:
Title
Usability: Visibility
Description
Visibility measured by surgeon usability questionnaire.
Time Frame
Operatively
Title
Usability: Access
Description
Access measured by surgeon usability questionnaire
Time Frame
Operatively
Title
Usability: Manueverability
Description
Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate
Time Frame
Operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is able to understand and sign Informed Consent Form. The subject is between 18-85 years of age. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision. Exclusion Criteria: Any female patient, who is pregnant, suspected pregnant, or nursing. The participant is unable or unwilling to comply with the study requirements, follow-up schedule. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Providence Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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Radial Reload Open LAR Case Series

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