Tympanic Membrane PerforationNCT07823894
Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty
A study testing Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft in people with Tympanic Membrane Perforation and Chronic Otitis Media, run by Assiut University.
Trial summary
This study evaluates the anatomical and functional outcomes of using a boomerang-shaped chondroperichondrial graft in endoscopic Type I tympanoplasty for repairing anterior or subtotal tympanic membrane perforations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanic Membrane Perforation, Chronic Otitis Media
- What is being tested?
- Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Anterior or subtotal tympanic membrane perforation
- Dry ear for at least 3 months prior to surgery
- Intact and mobile ossicular chain on clinical and intraoperative assessment
- Aerated middle ear with healthy or near-normal middle ear mucosa
- No evidence of cholesteatoma
- Ability to attend all scheduled postoperative follow-up visits
- Provision of written informed consent
Who cannot join
- Active ear discharge at the time of surgery
- Presence of cholesteatoma
- Marginal or attic perforation associated with pathology requiring mastoid surgery
- Ossicular discontinuity or erosion requiring ossiculoplasty
- Significant adhesive otitis media
- Previous failed tympanoplasty in the same ear
Show all 11Show fewer
- Severe Eustachian tube dysfunction associated with adhesive disease
- Craniofacial anomalies affecting the ear
- Uncontrolled systemic disease contraindicating surgery
- Narrow external auditory canal precluding endoscopic access
- Inability to complete the planned follow-up period
About this study
Official title: Boomerang-Shaped Cartilage/Perichondrial Graft in Endoscopic Tympanoplasty for Anterior or Subtotal Tympanic Membrane Perforations
This study evaluates the anatomical and functional outcomes of using a boomerang-shaped chondroperichondrial graft in endoscopic Type I tympanoplasty for repairing anterior or subtotal tympanic membrane perforations.
Anterior and subtotal eardrum perforations represent challenging surgical scenarios due to limited visualization, lack of anterior graft support, and higher risks of graft retraction, medialization, or residual perforation. The boomerang-shaped cartilage and perichondrium graft provides a sturdy cartilage framework along the anterior border to secure structural support, while maintaining a thin perichondrial layer over the functional vibratory area to facilitate acoustic transmission.
All enrolled participants undergo endoscopic Type I tympanoplasty using this autologous grafting technique. Follow-up assessments are conducted at 1, 3, and 6 months after surgery to determine successful graft uptake, evaluate hearing improvement (via pure-tone audiometry and air-bone gap closure), and monitor for complications such as blunting, retraction, lateralization, or infection.
- Being tested
- Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft
- Keywords
- Endoscopic tympanoplasty, Type 1 tympanoplasty, Boomerang-shaped graft, Chondroperichondrial graft, Cartilage tympanoplasty, Anterior perforation, Subtotal perforation, Graft uptake
- 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.
Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial GraftProcedure or surgery
Endoscopic Type I tympanoplasty performed using a rigid endoscope to repair anterior or subtotal tympanic membrane perforations. The autologous boomerang-shaped chondroperichondrial graft provides a stable anterior cartilage framework to prevent graft medialization, retraction, and residual perforation, while preserving a thin perichondrial layer over the functional vibratory surface to optimize acoustic transfer. Anatomical graft uptake and complication rates are monitored at 1, 3, and 6 months postoperatively, and functional hearing outcomes (pure-tone audiometry thresholds and air-bone gap closure) are measured at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Boomerang-Shaped Chondroperichondrial Graft | Experimental | Patients undergo endoscopic Type I tympanoplasty using an autologous boomerang-shaped chondroperichondrial graft for the repair of anterior or subtotal tympanic membrane perforations. Graft uptake, audiometric outcomes (pure-tone audiometry thresholds and air-bone gap closure), and postoperative complications are assessed over a 6-month follow-up period. Receives: Procedure: Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Uptake Rate
Percentage of patients achieving complete anatomical closure and intact healing of the tympanic membrane perforation without residual defect, verified by postoperative otoscopic and endoscopic examination.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Asaad Ibrahim Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823894
- Sponsor's protocol ID
- Boomerang Graft Tympanoplasty
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boomerang-Shaped Cartilage/Perichondrial Graft in Endoscopic Tympanoplasty for Anterior or Subtotal Tympanic Membrane Perforations
- ClinicalTrials.gov ID
- NCT07823894
- Acronym / sponsor ID
- Boomerang Graft Tympanoplasty
- Keywords
- Endoscopic tympanoplasty, Type 1 tympanoplasty, Boomerang-shaped graft, Chondroperichondrial graft, Cartilage tympanoplasty, Anterior perforation, Subtotal perforation, Graft uptake
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Sep 2026 (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.
This study evaluates the anatomical and functional outcomes of using a boomerang-shaped chondroperichondrial graft in endoscopic Type I tympanoplasty for repairing anterior or subtotal tympanic membrane perforations.
Anterior and subtotal eardrum perforations represent challenging surgical scenarios due to limited visualization, lack of anterior graft support, and higher risks of graft retraction, medialization, or residual perforation. The boomerang-shaped cartilage and perichondrium graft provides a sturdy cartilage framework along the anterior border to secure structural support, while maintaining a thin perichondrial layer over the functional vibratory area to facilitate acoustic transmission.
All enrolled participants undergo endoscopic Type I tympanoplasty using this autologous grafting technique. Follow-up assessments are conducted at 1, 3, and 6 months after surgery to determine successful graft uptake, evaluate hearing improvement (via pure-tone audiometry and air-bone gap closure), and monitor for complications such as blunting, retraction, lateralization, or infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boomerang-Shaped Chondroperichondrial Graft | Experimental | Procedure: Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial GraftPatients undergo endoscopic Type I tympanoplasty using an autologous boomerang-shaped chondroperichondrial graft for the repair of anterior or subtotal tympanic membrane perforations. Graft uptake, audiometric outcomes (pure-tone audiometry thresholds and air-bone gap closure), and postoperative complications are assessed over a 6-month follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Anterior or subtotal tympanic membrane perforation
- Dry ear for at least 3 months prior to surgery
- Intact and mobile ossicular chain on clinical and intraoperative assessment
- Aerated middle ear with healthy or near-normal middle ear mucosa
Key exclusion criteria (11 listed)
- Active ear discharge at the time of surgery
- Presence of cholesteatoma
- Marginal or attic perforation associated with pathology requiring mastoid surgery
- Ossicular discontinuity or erosion requiring ossiculoplasty
- Significant adhesive otitis media
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 |
|---|---|---|
| Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial GraftEndoscopic Type I tympanoplasty performed using a rigid endoscope to repair anterior or subtotal tympanic membrane perforations. The autologous boomerang-shaped chondroperichondrial graft provides a stable anterior cartilage framework to prevent graft medialization, retraction, and residual perforation, while preserving a thin perichondrial layer over the functional vibratory surface to optimize acoustic transfer. Anatomical graft uptake and complication rates are monitored at 1, 3, and 6 months postoperatively, and functional hearing outcomes (pure-tone audiometry thresholds and air-bone gap closure) are measured at 6 months. | Procedure or surgery | Boomerang-Shaped Chondroperichondrial Graft |
Primary outcome
Graft Uptake Rate
Time frame: 6 months postoperatively
Percentage of patients achieving complete anatomical closure and intact healing of the tympanic membrane perforation without residual defect, verified by postoperative otoscopic and endoscopic examination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft in people with Tympanic Membrane Perforation and Chronic Otitis Media, run by Assiut University.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Uptake Rate (time frame: 6 months postoperatively). 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 17 Sep 2026.