Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil" (NCT06542367) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
20 participantsStarted 2024-09-01
Plain-language summary
Eligible participants with chronic tympanic membrane perforation (\>6 month) will be given a detailed description and offered to participate in the study.
the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.
Who can participate
Age range
18 Years – 99 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:
* Chronic tympanic membrane perforation (\>6 months).
* Central tympanic membrane perforation.
* Air bone gar of 35 dB or lower at the operated ear.
* No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.
* No evidence of a retraction pocket and no suspicion for a cholesteatoma.
Exclusion Criteria:
* Known ossicular chain dysfunction
* The tympanic membrane perforation edges are not accessible/visualized transcanal
* Pregnancy
* Allergy to lidocaine
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.