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

Completed · Not applicable

Conditions studied: Hemorrhoid

In brief

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.

Key facts

Study ID

NCT01169311

Run by

Medtronic - MITG

People needed

27

Starts

2010-07-01

Expected to finish

2011-07-01

Last updated by the study team

2014-10-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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