Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and TachoSil

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06542367

Enrollment

Registered

2024-08-07

Start date

2024-09-01

Completion date

2026-09-01

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanic Membrane Perforation

Keywords

Tympanoplasty

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 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.

Interventions

PROCEDURETympanoplasty performed under local anesthesia using fat graft and Tachosil.

Under local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the Tachosil on top of the fat graft. gelfoam is placed lateral to the tympanic membrane to fill the ear canal. follow-up will be held at 2, 4-6 and 12 months following the procedure, with audiometric and otological evaluation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
closure of tympanic membrane perforation	1 year following the procedure	the effectiveness of the tympanoplasty using far graft and Tachosil will be evaluated - whether close of tympanic membrane perforation occured.

Secondary

Measure	Time frame	Description
Hearing results following tympanoplasty - Speech recognition threshold	1 year following the procedure	SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Hearing results following tympanoplasty - Pure Tone Average	1 year following the procedure	PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Hearing results following tympanoplasty - air bone gap.	1 year following the procedure	Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.

Contacts

Primary Contactyoni Evgeni Gutkovich, M.D/Ph.D

yonigo@clalit.org.il+972-46495563

Backup ContactLev Shlizerman, M.D

lev_sh@clalit.org.il+972-46495563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026