Mastoid CavityNCT06116513
Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass
An observational study of Mastoid Cavity, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
Trial summary
In canal wall down surgeries, the posterior bony wall of the external auditory canal (EAC) is removed to increase exposure. The creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mastoid Cavity
- What is being tested?
- S53P4 bioactive glass granules
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2021to 1 Jan 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients operated in our hospital between 2011 and 2022 for troublesome radical cavities that received secondary obliteration
Who may be able to join
- Old canal wall down cavity
- Operated between 2011 and 2022
Who cannot join
- Middle ear cholesteatoma
- Previous obliteration
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Diakonessenhuis
Utrecht, 3582KE
088 250 5000
About this study
Official title: Efficacy of Secondary Obliteration of Chronically Discharging Old Radical Cavities Using S53P4 Bioactive Glass
In canal wall down surgeries, the posterior bony wall of the external auditory canal (EAC) is removed to increase exposure. The creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and dizziness. Secondary obliteration of the mastoid cavity and reconstruction of the posterior wall of the EAC can help alleviate these symptoms. Our goal is to study the efficacy of secondary obliteration using S53P4 bioactive glass as obliteration material. This bioactive glass has several important characteristics, such as retaining of volume over time and antibacterial effects. The main outcome will be postoperative otorrhea as indicated by the Merchant grading scale.
- Conditions
- Mastoid Cavity
- Being tested
- S53P4 bioactive glass granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S53P4 bioactive glass granulesDevice
During revision surgery, all infectious material would be removed and subsequently the posterior wall of the external ear canal would be reconstructed and the mastoid would be obliterated using S53P4 bioactive glass.
| Study group | Role | What they receive |
|---|---|---|
| Patients with old troublesome radical cavities | These patients would have old Canal Wall Down cavities that were troublesome Receives: Device: S53P4 bioactive glass granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number or participants with a dry ear pre- and postoperatively
Postoperative otorrhea as indicated by the Merchant grading system. Grade 0-1 was defined as control of infection and grade 2-3 was defined as failure.
Measured: At 1, 3 and 5-year postoperatively.
Secondary outcomes (3)
Pre- and postoperative air conduction
Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air conduction in decibel.
Measured: pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
Pre- and postoperative air-bone gap
Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air-bone gap in decibel.
Measured: pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
The number of patients with postoperative surgical complications
Complications that occured within the first year following surgery
Measured: First year following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastoid CavityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonessenhuis, Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.J. Quak, MD, PhD, Principal investigator, Diakonessenhuis, Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116513
- Sponsor's protocol ID
- 16-004-1
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Secondary Obliteration of Chronically Discharging Old Radical Cavities Using S53P4 Bioactive Glass
- ClinicalTrials.gov ID
- NCT06116513
- Acronym / sponsor ID
- 16-004-1
- Conditions
- Mastoid Cavity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Diakonessenhuis, UtrechtUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 Nov 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.
In canal wall down surgeries, the posterior bony wall of the external auditory canal (EAC) is removed to increase exposure. The creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and dizziness. Secondary obliteration of the mastoid cavity and reconstruction of the posterior wall of the EAC can help alleviate these symptoms. Our goal is to study the efficacy of secondary obliteration using S53P4 bioactive glass as obliteration material. This bioactive glass has several important characteristics, such as retaining of volume over time and antibacterial effects. The main outcome will be postoperative otorrhea as indicated by the Merchant grading scale.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with old troublesome radical cavities | – | Device: S53P4 bioactive glass granulesThese patients would have old Canal Wall Down cavities that were troublesome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients operated in our hospital between 2011 and 2022 for troublesome radical cavities that received secondary obliteration
Key inclusion criteria (2 listed)
- Old canal wall down cavity
- Operated between 2011 and 2022
Key exclusion criteria (2 listed)
- Middle ear cholesteatoma
- Previous obliteration
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 |
|---|---|---|
| S53P4 bioactive glass granulesDuring revision surgery, all infectious material would be removed and subsequently the posterior wall of the external ear canal would be reconstructed and the mastoid would be obliterated using S53P4 bioactive glass. | Device | Patients with old troublesome radical cavities |
Primary outcome
Number or participants with a dry ear pre- and postoperatively
Time frame: At 1, 3 and 5-year postoperatively.
Postoperative otorrhea as indicated by the Merchant grading system. Grade 0-1 was defined as control of infection and grade 2-3 was defined as failure.
3 secondary outcomes
Pre- and postoperative air conduction
Time frame: pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
Pre- and postoperative air-bone gap
Time frame: pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
The number of patients with postoperative surgical complications
Time frame: First year following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- 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.
J.J. Quak, MD, PhD principal investigator
Diakonessenhuis, Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastoid Cavity, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
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 2 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 3 Nov 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 Netherlands. 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 Leij-Halfwerk, Msc, Ir (088-250 6172, Wetenschapsbureau@diakhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number or participants with a dry ear pre- and postoperatively (time frame: At 1, 3 and 5-year 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 3 Nov 2023.