Ossicle Chain DisarticulationNCT05813990
Reconstructive Ear Surgery in Pediatrics
A study testing recostructive ear surgery in people with Ossicle Chain Disarticulation, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study is 1. Evaluation of preoperative degree of hearing loss in pediatric population. 2. Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma. 3. Assessment of best candidates for hearing restoration surgeries. 4. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Ossicle Chain Disarticulation
- What is being tested?
- recostructive ear surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2022to Dec 2024
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients aged ≤ 18years with CHL.
- patients who are candidate for ossiculoplasty as surgical treatment for them.
Who cannot join
- Patients with preoperative sensory neural hearing loss (SNHL).
- Patient with intra operative complications.
- Patients with intracranial and intratemporal complications.
- Patients with stapes foot plate fixation, broken graft and missed patients.
- Patients >18years.
- Patients who unfit for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study
The aim of the study is
- Evaluation of preoperative degree of hearing loss in pediatric population.
- Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma.
- Assessment of best candidates for hearing restoration surgeries.
- Comparing different surgical techniques for hearing restoration in various ossicular disorders .
- Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.
Read the detailed description
Conductive hearing loss (CHL) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. A variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ.
Ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. Ossiculoplasty has been performed as early as the 1950s.A myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment.
Pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. Various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established
- Conditions
- Ossicle Chain Disarticulation
- Being tested
- recostructive ear surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recostructive ear surgeryOther
Also called ossiculoplasty
recostructive ear surgery in pediatric population
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patient with conductive hearing loss | Other | All pediatric patients aged below 18 years old will subjected to reconstructive ear surgery (ossiculoplasty) Receives: Other: recostructive ear surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
reconstuctive ear surgery in pediartic population
Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population using audiometry 2 months, 6month and 1 year after surgery to assess hearing results and prosthesis stability.
Measured: 2m,6m and 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start22 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ossicle Chain DisarticulationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeinab salah eldin mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813990
- Sponsor's protocol ID
- ossiculoplasty in pediatrics
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamrava B, Roehm PC. Systematic Review of Ossicular Chain Anatomy: Strategic Planning for Development of Novel Middle Ear Prostheses. Otolaryngol Head Neck Surg. 2017 Aug;157(2):190-200. doi: 10.1177/0194599817701717. Epub 2017 May 2.
PubMed 28463590
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05813990
- Acronym / sponsor ID
- ossiculoplasty in pediatrics
- Conditions
- Ossicle Chain Disarticulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Apr 2023 (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.
The aim of the study is
- Evaluation of preoperative degree of hearing loss in pediatric population.
- Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma.
- Assessment of best candidates for hearing restoration surgeries.
- Comparing different surgical techniques for hearing restoration in various ossicular disorders .
- Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.
Detailed description
Conductive hearing loss (CHL) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. A variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ.
Ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. Ossiculoplasty has been performed as early as the 1950s.A myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment.
Pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. Various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patient with conductive hearing loss | Other | Other: recostructive ear surgeryAll pediatric patients aged below 18 years old will subjected to reconstructive ear surgery (ossiculoplasty) |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients aged ≤ 18years with CHL.
- patients who are candidate for ossiculoplasty as surgical treatment for them.
Key exclusion criteria (6 listed)
- Patients with preoperative sensory neural hearing loss (SNHL).
- Patient with intra operative complications.
- Patients with intracranial and intratemporal complications.
- Patients with stapes foot plate fixation, broken graft and missed patients.
- Patients >18years.
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 |
|---|---|---|
| recostructive ear surgeryAlso: ossiculoplastyrecostructive ear surgery in pediatric population | Other | Pediatric patient with conductive hearing loss |
Primary outcome
reconstuctive ear surgery in pediartic population
Time frame: 2m,6m and 1year
Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population using audiometry 2 months, 6month and 1 year after surgery to assess hearing results and prosthesis stability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 28463590Kamrava B, Roehm PC. Systematic Review of Ossicular Chain Anatomy: Strategic Planning for Development of Novel Middle Ear Prostheses. Otolaryngol Head Neck Surg. 2017 Aug;157(2):190-200. doi: 10.1177/0194599817701717. Epub 2017 May 2.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recostructive ear surgery in people with Ossicle Chain Disarticulation, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 6 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 zeinab salah eldin mohamed, MD (01065475006, zeinab.sal2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reconstuctive ear surgery in pediartic population (time frame: 2m,6m and 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813990, which also lists 1 linked publication.
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 18 Apr 2023.