Radial Reload Open LAR Case Series

Medtronic

Status: Terminated

Conditions: Low Anterior Resection; Proctosigmoid Resection; Rectal Cancer

Treatments: Device: Covidien Radial Reload Stapler with Tri-Staple Technology

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01717014

COVLARO0286

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Covidien Radial Reload Stapler with Tri-Staple Technology

Experimental group

Description:

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

Treatment:

Device: Covidien Radial Reload Stapler with Tri-Staple Technology