Cartilage TympanoplastyNCT04815655
Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft
A study testing Cartilage tympanoplasty in people with Cartilage Tympanoplasty, run by Assiut University.
Trial summary
Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cartilage Tympanoplasty
- What is being tested?
- Cartilage tympanoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years
Who cannot join
- active infection
- sensorineural hearing loss
- compromised immune system 4 - patients age below 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.
Read the detailed description
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
- Conditions
- Cartilage Tympanoplasty
- Being tested
- Cartilage tympanoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartilage tympanoplastyProcedure or surgery
is the reconstruction of the tympanic membrane (TM) by using catilage
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage TympanoplastyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroleen Mounir Tawfik, Assiut University
- Investigators
- Hamza Elshafie, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815655
- Sponsor's protocol ID
- Cartilage tympanoplasty
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft
- ClinicalTrials.gov ID
- NCT04815655
- Acronym / sponsor ID
- Cartilage tympanoplasty
- Conditions
- Cartilage Tympanoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.
Detailed description
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years
Key exclusion criteria (3 listed)
- active infection
- sensorineural hearing loss
- compromised immune system 4 - patients age below 18 years
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 |
|---|---|---|
| Cartilage tympanoplastyis the reconstruction of the tympanic membrane (TM) by using catilage | Procedure or surgery | – |
Primary outcome
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
Time frame: 1 year
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Cartilage Tympanoplasty
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Not yet recruiting
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
Tympanic Membrane Perforation, Otitis Media
Not yet recruiting
Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruitingObservational study
Partial Thickness vs Full Thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty
Tympanoplasty Surgery
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.
Hamza Elshafie, Professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Cartilage tympanoplasty in people with Cartilage Tympanoplasty, 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 1 inclusion and 3 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 25 Mar 2021. 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 Caroleen Mounir, Resident (01206045590, Caroleenmounir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer (time frame: 1 year). 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 25 Mar 2021.