Status:
COMPLETED
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Lead Sponsor:
Medtronic - MITG
Conditions:
Hemorrhoid
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 nor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01169311
Start Date
July 1 2010
End Date
July 1 2011
Last Update
October 6 2014
Active Locations (1)
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1
Weill Cornell Medical Center
New York, New York, United States, 10065