Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidop… (NCT01169311) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
United States27 participantsStarted 2010-07
Plain-language 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 normal staple line safety as measured by the 30 day incidence of adverse events.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Uneventful Creation of a Functional Staple Line at First Firing of Device