OtosclerosisNCT06323863
Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation
An observational study of Otosclerosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis
- What is being tested?
- stapedectomy and ultra high resolution CT
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with otosclerosis who underwent stapes replacement by a prosthesis and underwent ultra high resolution CT for follow-up
Who may be able to join
- stapes prosthesis Ultra-high resolution CT available
Who cannot join
- no materiovigilance report available
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Nancy
Nancy, 54000
romain gillet, md, 00383851811, r.gillet@chru-nancy.fr
About this study
Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting.
Read the detailed description
Modern temporal bone imaging systems, using 0.5 mm slice thickness, are reputed not yet able to depict the stapes piston position with a sufficient degree of accuracy, as high-resolution CT measurements consistently overestimated intravestibular piston dimensions (width by 44%, length by 6.25%) and vestibular intrusion (by 39%) because of metallic artifacts. . The exact limits of intravestibular depth are also unclear. The "safe" intravestibular prosthesis depth varies widely between studies and has been reported to range from 0.2 to 2.5 mm, so 39% may represent up to 0.9 mm of misestimation. Ultra-high resolution CT (UHR-CT) has improved spatial resolution to 0.12 mm by using ultra-small detector elements (0.25 x 0.25 mm), allowing better visualization of temporal bone structures compared to high-resolution temporal bone CT (HR-CT). However, this technique has not been described for stapes prosthesis measurement.
- Conditions
- Otosclerosis
- Being tested
- stapedectomy, ultra high resolution CT
- Keywords
- stapes, titanium, computed tomography
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapedectomyProcedure or surgery
stapes removal and replacement by a prosthesis
ultra high resolution CTRadiation
imaging study
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent stapes surgery at our instution | patients with otosclerosis who underwent stapedectomy in our institution Receives: Procedure: stapedectomy; Radiation: ultra high resolution CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
length
length of the prosthesis on CT
Measured: february 2020 - novembre 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- romain gillet, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323863
- Sponsor's protocol ID
- N°4-RCB/EUDRACT
- Status last verified
- Nov 2023
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because CT-scanner are the patient's proprety
Publications
Bozzato A, Struffert T, Hertel V, Iro H, Hornung J. Analysis of the accuracy of high-resolution computed tomography techniques for the measurement of stapes prostheses. Eur Radiol. 2010 Mar;20(3):566-71. doi: 10.1007/s00330-009-1582-4. Epub 2009 Sep 2.
PubMed 19727746Fang Y, Wang B, Galvin JJ 3rd, Tao D, Deng R, Ou X, Liu Y, Dai P, Sha Y, Zhang T, Chen B. MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance. Otol Neurotol. 2016 Apr;37(4):321-3. doi: 10.1097/MAO.0000000000000987.
PubMed 26927761Gil Mun S, Scheffner E, Muller S, Mittmann P, Rademacher G, Mutze S, Wilms K, Boga E, Bjorn Gehl H, Sudhoff H, Todt I. Stapes piston insertion depth and clinical correlations. Acta Otolaryngol. 2019 Oct;139(10):829-832. doi: 10.1080/00016489.2019.1637019. Epub 2019 Jul 12.
PubMed 31298596
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation
- ClinicalTrials.gov ID
- NCT06323863
- Acronym / sponsor ID
- N°4-RCB/EUDRACT
- Conditions
- Otosclerosis
- Keywords
- stapes, titanium, computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Mar 2024 (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.
Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting.
Detailed description
Modern temporal bone imaging systems, using 0.5 mm slice thickness, are reputed not yet able to depict the stapes piston position with a sufficient degree of accuracy, as high-resolution CT measurements consistently overestimated intravestibular piston dimensions (width by 44%, length by 6.25%) and vestibular intrusion (by 39%) because of metallic artifacts. . The exact limits of intravestibular depth are also unclear. The "safe" intravestibular prosthesis depth varies widely between studies and has been reported to range from 0.2 to 2.5 mm, so 39% may represent up to 0.9 mm of misestimation. Ultra-high resolution CT (UHR-CT) has improved spatial resolution to 0.12 mm by using ultra-small detector elements (0.25 x 0.25 mm), allowing better visualization of temporal bone structures compared to high-resolution temporal bone CT (HR-CT). However, this technique has not been described for stapes prosthesis measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent stapes surgery at our instution | – | Procedure: stapedectomy, Radiation: ultra high resolution CTpatients with otosclerosis who underwent stapedectomy in our institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with otosclerosis who underwent stapes replacement by a prosthesis and underwent ultra high resolution CT for follow-up
Key inclusion criteria (1 listed)
- stapes prosthesis Ultra-high resolution CT available
Key exclusion criteria (1 listed)
- no materiovigilance report available
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 |
|---|---|---|
| stapedectomystapes removal and replacement by a prosthesis | Procedure or surgery | patients who underwent stapes surgery at our instution |
| ultra high resolution CTimaging study | Radiation | patients who underwent stapes surgery at our instution |
Primary outcome
length
Time frame: february 2020 - novembre 2023
length of the prosthesis on CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 19727746Bozzato A, Struffert T, Hertel V, Iro H, Hornung J. Analysis of the accuracy of high-resolution computed tomography techniques for the measurement of stapes prostheses. Eur Radiol. 2010 Mar;20(3):566-71. doi: 10.1007/s00330-009-1582-4. Epub 2009 Sep 2.
- Background: PubMed 26927761Fang Y, Wang B, Galvin JJ 3rd, Tao D, Deng R, Ou X, Liu Y, Dai P, Sha Y, Zhang T, Chen B. MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance. Otol Neurotol. 2016 Apr;37(4):321-3. doi: 10.1097/MAO.0000000000000987.
- Background: PubMed 31298596Gil Mun S, Scheffner E, Muller S, Mittmann P, Rademacher G, Mutze S, Wilms K, Boga E, Bjorn Gehl H, Sudhoff H, Todt I. Stapes piston insertion depth and clinical correlations. Acta Otolaryngol. 2019 Oct;139(10):829-832. doi: 10.1080/00016489.2019.1637019. Epub 2019 Jul 12.
- Individual participant dataSharing planned: No. because CT-scanner are the patient's proprety
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
romain gillet principal investigator
CHRU de Nancy
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 Otosclerosis, run by Central Hospital, Nancy, France at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 France. 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 romain gillet, md (00.33680987216, r.gillet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length (time frame: february 2020 - novembre 2023). 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 NCT06323863, which also lists 3 linked publications.
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 21 Mar 2024.