Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

Medtronic

Status

Completed

Conditions

Hemorrhoid

Treatments

Device: Hemorrhoidopexy

Study type

Interventional

Funder types

Industry

Identifiers

COVHEPH0021

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.