Status:

NOT_YET_RECRUITING

Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"

Lead Sponsor:

HaEmek Medical Center, Israel

Conditions:

Tympanic Membrane Perforation

Eligibility:

All Genders

18-99 years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • Known ossicular chain dysfunction
  • The tympanic membrane perforation edges are not accessible/visualized transcanal
  • Pregnancy
  • Allergy to lidocaine

Key Trial Info

Start Date :

September 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06542367

Start Date

September 1 2024

End Date

September 1 2026

Last Update

August 13 2024

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