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Radial Reload Laparoscopic LAR Case Series

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 4
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 Colorectal Cancer

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.
  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.

Sites / Locations

  • University Hospitals Case 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 laparoscopic LAR or proctosigmoidectomy

Outcomes

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
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
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
1. Access measured by surgeon usability questionnaire.
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
2. Visibility measured by surgeon usability questionnaire
Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate

Full Information

First Posted
October 11, 2012
Last Updated
March 17, 2015
Sponsor
Medtronic - MITG
Collaborators
University Hospitals Cleveland Medical Center, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01706822
Brief Title
Radial Reload Laparoscopic LAR Case Series
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
April 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
University Hospitals Cleveland Medical Center, Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
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 laparoscopic LAR or proctosigmoidectomy
Intervention Type
Device
Intervention Name(s)
Covidien Radial Reload Stapler with Tri-Staple Technology
Intervention Description
Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler
Primary Outcome Measure Information:
Title
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
Description
The surgeon's ability to achieve a staple line at the desired level of the rectum.
Time Frame
Operative
Title
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
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
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
Description
1. Access measured by surgeon usability questionnaire.
Time Frame
Operatively
Title
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
Description
2. Visibility measured by surgeon usability questionnaire
Time Frame
Operatively
Title
Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree
Description
3. Maneuverability 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. The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conor Delaney, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Radial Reload Laparoscopic LAR Case Series

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