Mastoid CavityNCT06160388
The Safety of S53P4 Bioactive Glass for Mastoid Obliteration
An observational study of Mastoid Cavity, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
Trial summary
In recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume… 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
- Type of treatment
- Medical device
- How many people
- 1,196 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to 1 Mar 2025
- 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 that were operated in our hospital using a canal wall up or canal wall down mastoidectomy between 2010 and 2022.
Who may be able to join
- Canal wall up or canal wall down mastoidectomy
- Operated between 2010 and 2022
- All indications are included
Who cannot join
- Other surgical techniques, such as subtotal petrosectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short- and Long-Term Safety of S53P4 Bioactive Glass for Mastoid Obliteration: a Retrospective Comparative Study
In recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume over time and have no risk of donor site morbidity. Comparative studies between materials are rare and the few available were unable to ascertain superiority.
Our hospital has been utilizing the same material for obliteration since 2011: S53P4 bioactive glass (BAG). It since has become our main operating procedure to obliterate the mastoid cavity with BAG granules following both canal wall up (CWU) and canal wall down (CWD) mastoidectomy. This bioactive glass has several important characteristics, such as the retaining of volume over time and antibacterial properties.
An important factor when selecting obliteration material is safety. Data on this was reported in several studies, but unfortunately these studies only investigated short-term safety in small and selected cohorts of patients, often without comparison. Additionally, large studies with extensive follow-up are necessary to detect rare complications and long-term pitfalls. Therefore, the aim of this study is to determine the safety of BAG in a cohort that encompasses all cases that underwent CWU+MO and CWD+MO in our institute and compare these results to a non-obliteration cohort. The main outcomes are short- and long-term safety, as indicated by surgical complications in the first year following surgery and revision surgeries during follow-up, respectively. The investigators will compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries
- Conditions
- Mastoid Cavity
- Being tested
- S53P4 Bioactive glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S53P4 Bioactive glassDevice
Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.
| Study group | Role | What they receive |
|---|---|---|
| Patients that underwent mastoidectomy + mastoid obliteration using bioactive glass | This is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy followed by obliteration of the mastoid cavity using S53P4 bioactive glass for any indication Receives: Device: S53P4 Bioactive glass | |
| Patients that underwent mastoidectomy alone | This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy without mastoid obliteration for any indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with postoperative surgical complications in the first year following surgery
Complications that occured within the first year following surgery
We compare the obliteration cohort to the non-obliterative cohort
Measured: First year following surgery
The number of patients which require revision surgery during follow-up
Revision surgeries performed during follow-up due to problems with the obliteration
Measured: At 3-, 5- and 8-years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2023
- Primary completion1 Sep 2024
- Study completion1 Mar 2025
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
- 1,196 participants (actual)
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
- NCT06160388
- Sponsor's protocol ID
- 16-004-3
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2023
- Last updated
- 14 Jul 2025
- 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short- and Long-Term Safety of S53P4 Bioactive Glass for Mastoid Obliteration: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT06160388
- Acronym / sponsor ID
- 16-004-3
- Conditions
- Mastoid Cavity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,196 participants (actual)
- Lead sponsor
- Diakonessenhuis, UtrechtUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 7 Dec 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 recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume over time and have no risk of donor site morbidity. Comparative studies between materials are rare and the few available were unable to ascertain superiority.
Our hospital has been utilizing the same material for obliteration since 2011: S53P4 bioactive glass (BAG). It since has become our main operating procedure to obliterate the mastoid cavity with BAG granules following both canal wall up (CWU) and canal wall down (CWD) mastoidectomy. This bioactive glass has several important characteristics, such as the retaining of volume over time and antibacterial properties.
An important factor when selecting obliteration material is safety. Data on this was reported in several studies, but unfortunately these studies only investigated short-term safety in small and selected cohorts of patients, often without comparison. Additionally, large studies with extensive follow-up are necessary to detect rare complications and long-term pitfalls. Therefore, the aim of this study is to determine the safety of BAG in a cohort that encompasses all cases that underwent CWU+MO and CWD+MO in our institute and compare these results to a non-obliteration cohort. The main outcomes are short- and long-term safety, as indicated by surgical complications in the first year following surgery and revision surgeries during follow-up, respectively. The investigators will compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients that underwent mastoidectomy + mastoid obliteration using bioactive glass | – | Device: S53P4 Bioactive glassThis is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy followed by obliteration of the mastoid cavity using S53P4 bioactive glass for any indication |
| Patients that underwent mastoidectomy alone | – | –This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy without mastoid obliteration for any indication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that were operated in our hospital using a canal wall up or canal wall down mastoidectomy between 2010 and 2022.
Key inclusion criteria (3 listed)
- Canal wall up or canal wall down mastoidectomy
- Operated between 2010 and 2022
- All indications are included
Key exclusion criteria (1 listed)
- Other surgical techniques, such as subtotal petrosectomy
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 glassFollowing mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit. | Device | Patients that underwent mastoidectomy + mastoid obliteration using bioactive glass |
Primary outcome
The number of patients with postoperative surgical complications in the first year following surgery
Time frame: First year following surgery
Complications that occured within the first year following surgery We compare the obliteration cohort to the non-obliterative cohort
The number of patients which require revision surgery during follow-up
Time frame: At 3-, 5- and 8-years postoperatively
Revision surgeries performed during follow-up due to problems with the obliteration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients with postoperative surgical complications in the first year following surgery (time frame: First year following surgery). The study lists 2 primary outcomes in all. 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 14 Jul 2025.