Suturable DuraGen™ PMCF Study (NCT04923867) | Clinical Trial Compass
CompletedNot Applicable
Suturable DuraGen™ PMCF Study
United States106 participantsStarted 2021-04-28
Plain-language summary
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
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
. Subject is between 18 and 80 years of age
. Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
. Availability of post-operative assessment results.
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.
1Since this is a post-market study of Suturable DuraGen, does that mean the device is already approved and in use, and how does that affect what's known about its safety compared to a first-in-human trial?
2This study was tracking 'patient outcomes' as its primary measure — can you tell me what specific results or complications were being monitored, and whether any findings from this completed study are relevant to my situation with cerebrospinal fluid leak?
3Since the trial is already completed, would it be possible to see or discuss the collected data or results, and could those findings influence how you might approach my treatment?
4Are there standard surgical or non-surgical options for managing a cerebrospinal fluid leak that I should consider alongside or instead of what was studied here, and how does Suturable DuraGen compare to those alternatives?
5Given that this was a post-market clinical follow-up study rather than a controlled trial, how confident can we be in drawing conclusions from its findings about whether this device is the right choice for my specific type of CSF leak?
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.