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 range
18 Years – 80 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Uneventful Creation of a Functional Staple Line at First Firing of Device