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Radial Reload Open LAR Case Series

This study has been terminated.
Sponsor:
Collaborators:
Duke University
Providence Medical Research Center
University of South Florida
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01717014
First received: October 26, 2012
Last updated: February 13, 2015
Last verified: February 2015
Results First Received: February 13, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Low Anterior Resection
Proctosigmoid Resection
Rectal Cancer
Intervention: Device: Covidien Radial Reload Stapler with Tri-Staple Technology

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Covidien Radial Reload Stapler With Tri-Staple Technology Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy

Participant Flow:   Overall Study
    Covidien Radial Reload Stapler With Tri-Staple Technology
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Covidien Radial Reload Stapler With Tri-Staple Technology Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy

Baseline Measures
   Covidien Radial Reload Stapler With Tri-Staple Technology 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.6  (14.8) 
Gender 
[Units: Participants]
 
Female   2 
Male   6 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   8 
More than one race   0 
Unknown or Not Reported   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   8 
Unknown or Not Reported   0 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 175.1  (4.3) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 88.7  (18.0) 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 29.0  (6.1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Staple Line   [ Time Frame: Operative ]

2.  Primary:   Distal Margins   [ Time Frame: Operative ]

3.  Secondary:   Usability: Visibility   [ Time Frame: Operatively ]

4.  Secondary:   Usability: Access   [ Time Frame: Operatively ]

5.  Secondary:   Usability: Manueverability   [ Time Frame: Operatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Julie Doyle
Organization: Covidien
phone: 781-839-1729
e-mail: Julie.Doyle@Covidien.com



Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01717014     History of Changes
Other Study ID Numbers: COVLARO0286
Study First Received: October 26, 2012
Results First Received: February 13, 2015
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration