A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure

Medtronic - MITG1 site in 1 country27 target enrollmentJuly 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hemorrhoid
Sponsor: Medtronic - MITG
Enrollment: 27
Locations: 1
Primary Endpoint: Uneventful Creation of a Functional Staple Line at First Firing of Device
Status: Completed
Last Updated: 11 years ago

Trial Objectives

The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:

overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

July 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Able to understand and sign Informed Consent Form
•The participant must be 18-80 years of age.
•The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

•The procedure is needed as revision hemorrhoid surgery.
•The participant is pregnant.
•The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
•The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
•The participant has a history of drug or alcohol abuse.
•The participant has a history of venous thrombosis or pulmonary embolism.
•The participant has a history of coagulopathy.
•The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
•The participant has a history of fecal incontinence.
•The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.