Radial Reload Laparoscopic LAR Case Series

Medtronic

Status and phase: Terminated; Phase 4

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01706822

COVLARL0287

Details and patient eligibility

About

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.

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.
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.

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 laparoscopic LAR or proctosigmoidectomy

Treatment:

Device: Covidien Radial Reload Stapler with Tri-Staple Technology