OtosclerosisTACOSNCT02435446
Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS)
A study testing Cone-beam computed tomography in people with Otosclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis. The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis
- What is being tested?
- Cone-beam computed tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2015to 2 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis
Who cannot join
- Pregnancy
- Breast feeding
- Patient under a legal protection procedure
- Patient denying to participate to the study
- Lack of affiliation to a social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis
Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis.
The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT.
In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis.
The results of the CBCT will be compared to those of the CT scan.
- Conditions
- Otosclerosis
- Being tested
- Cone-beam 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.
Cone-beam computed tomographyDevice
Cone-beam computed tomography
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients for cone-beam | Experimental | A cone-beam computed tomography will be offered to the patients undergoing a CT scan for the diagnosis and/or the pre-operative assessment of an otosclerosis, fulfilling the inclusion criterias and without any exclusion criteria. Receives: Device: Cone-beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start28 Oct 2015
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Why it stopped: PROBLEM of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435446
- Sponsor's protocol ID
- MWS_2015_18
- Acronym
- TACOS
- Status last verified
- Nov 2020
- First submitted
- 28 Apr 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis
- ClinicalTrials.gov ID
- NCT02435446
- Acronym / sponsor ID
- TACOS / MWS_2015_18
- Conditions
- Otosclerosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PROBLEM of inclusion
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis.
The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT.
In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis.
The results of the CBCT will be compared to those of the CT scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients for cone-beam | Experimental | Device: Cone-beam computed tomographyA cone-beam computed tomography will be offered to the patients undergoing a CT scan for the diagnosis and/or the pre-operative assessment of an otosclerosis, fulfilling the inclusion criterias and without any exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis
Key exclusion criteria (5 listed)
- Pregnancy
- Breast feeding
- Patient under a legal protection procedure
- Patient denying to participate to the study
- Lack of affiliation to a social security system
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 |
|---|---|---|
| Cone-beam computed tomographyCone-beam computed tomography | Device | Eligible patients for cone-beam |
Primary outcome
Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis
Time frame: 1 minute
Results and safety
The study was stopped early (reason given: PROBLEM of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone-beam computed tomography in people with Otosclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild 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 5 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: stopped early, as of the sponsor's last update on 4 Nov 2020. 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?
The study was stopped early (reason given: PROBLEM of inclusion). Results are not available in the source record.
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?
Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis (time frame: 1 minute). 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 4 Nov 2020.