Radial Reload Open LAR Case Series

Rectal Cancer Clinical Trial

Official title:

Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01717014
• Other study ID #: COVLARO0286
• Status: Terminated
• Phase: N/A
• First received: October 26, 2012
• Last updated: February 13, 2015
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Anterior Resection
• Proctosigmoid Resection
• Rectal Cancer

Intervention

Device:
• Covidien Radial Reload Stapler with Tri-Staple Technology
Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Providence Medical Center	Spokane	Washington
United States	University of South Florida	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Medtronic - MITG	Duke University, Providence Medical Research Center, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staple Line	The surgeons ability to achieve a staple line at the desired level of the rectum.	Operative	No
Primary	Distal Margins	The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.	Operative	No
Secondary	Usability: Visibility	Visibility measured by surgeon usability questionnaire.	Operatively	No
Secondary	Usability: Access	Access measured by surgeon usability questionnaire	Operatively	No
Secondary	Usability: Manueverability	Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate	Operatively	No