Radial Reload Open LAR Case Series

Stopped early · Not applicable

Conditions studied: Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer

In brief

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.

Key facts

Study ID

NCT01717014

Run by

Medtronic - MITG

People needed

8

Starts

2013-05-01

Expected to finish

2013-11-01

Last updated by the study team

2015-03-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Florida — Tampa, Florida, United States
• Duke University — Durham, North Carolina, United States
• Providence Medical Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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