Tympanic Membrane PerforationNCT06542367
Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
A study testing Tympanoplasty performed under local anesthesia using fat graft and "Tachosil". in people with Tympanic Membrane Perforation, run by HaEmek Medical Center, Israel.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known ossicular chain dysfunction
- The tympanic membrane perforation edges are not accessible/visualized transcanal
- Pregnancy
- Allergy to lidocaine
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".
- Keywords
- Tympanoplasty
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil" | Experimental | eligibale participatns with chronic tympanic membrane perforation will be offered to participate.
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 fo fill the ear canal. follow-up will be held at 2, 4-6 and 12 month following the procedure, with audiometric and otological evaluation Receives: Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil". |
What is being measured
The primary outcome is the main question the study is designed to answer.
closure of tympanic membrane perforation
the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.
Measured: 1 year following the procedure
Secondary outcomes (3)
Hearing results following tympanoplasty - Speech recognition threshold
SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Measured: 1 year following the procedure
Hearing results following tympanoplasty - Pure Tone Average
PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Measured: 1 year following the procedure
Hearing results following tympanoplasty - air bone gap.
Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Measured: 1 year following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoni Evgeni Gutkovich, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542367
- Sponsor's protocol ID
- 0047-24-EMC
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
- ClinicalTrials.gov ID
- NCT06542367
- Acronym / sponsor ID
- 0047-24-EMC
- Conditions
- Tympanic Membrane Perforation
- Keywords
- Tympanoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil" | Experimental | Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".eligibale participatns with chronic tympanic membrane perforation will be offered to participate. 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 fo fill the ear canal. follow-up will be held at 2, 4-6 and 12 month following the procedure, with audiometric and otological evaluation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Known ossicular chain dysfunction
- The tympanic membrane perforation edges are not accessible/visualized transcanal
- Pregnancy
- Allergy to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tympanoplasty 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 | Procedure or surgery | Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil" |
Primary outcome
closure of tympanic membrane perforation
Time frame: 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.
3 secondary outcomes
Hearing results following tympanoplasty - Speech recognition threshold
Time frame: 1 year following the procedure
Hearing results following tympanoplasty - Pure Tone Average
Time frame: 1 year following the procedure
Hearing results following tympanoplasty - air bone gap.
Time frame: 1 year following the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tympanoplasty performed under local anesthesia using fat graft and "Tachosil". in people with Tympanic Membrane Perforation, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yoni Evgeni Gutkovich, M.D/Ph.D (+972-46495563, yonigo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
closure of tympanic membrane perforation (time frame: 1 year following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.