Radial Reload Open LAR Case Series

NCT01717014 | Terminated Results

• 1 other identifier: COVLARO0286
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Low Anterior Resection; Proctosigmoid Resection; Rectal Cancer

Keywords

rectal cancer; stapler

Outcome Measures

Primary Outcomes (2)

• Staple Line

  The surgeons ability to achieve a staple line at the desired level of the rectum.

  Operative

• Distal Margins

  The ability to achieve adequate distal margins (defined as \>2cm \[or \>1cm with clear histologic evaluation\]) in the low rectum.

  Operative

Secondary Outcomes (3)

• Usability: Visibility

  Operatively

• Usability: Access

  Operatively

• Usability: Manueverability

  Operatively

Study Arms (1)

Covidien Radial Reload Stapler with Tri-Staple Technology

EXPERIMENTAL

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

Device: Covidien Radial Reload Stapler with Tri-Staple Technology

Interventions

Covidien Radial Reload Stapler with Tri-Staple Technology DEVICE

Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler

Covidien Radial Reload Stapler with Tri-Staple Technology

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medtronic - MITG: lead
• Duke University: collaborator
• Providence Medical Research Center: collaborator
• University of South Florida: collaborator

Study Sites (3)

University of South Florida

Tampa, Florida, 33606, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Providence Medical Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Julie Doyle
• Organization: Covidien

Julie.Doyle@Covidien.com

781-839-1729

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 2, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-02

Locations

US (3)