Radial Reload Open LAR Case Series

NCT ID: NCT01717014

Last Updated: 2015-03-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Low Anterior Resection Proctosigmoid Resection Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Covidien Radial Reload Stapler with Tri-Staple Technology

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

Group Type EXPERIMENTAL

Covidien Radial Reload Stapler with Tri-Staple Technology

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Providence Medical Research Center

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Providence Medical Center

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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COVLARO0286

Identifier Type: -

Identifier Source: org_study_id

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