Cochlear ImplantationR-PO18155NCT03950375
Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation
An observational study of Cochlear Implantation, run by CHU de Reims at 1 site in France.
Trial summary
The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implantation
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2018to 24 Apr 2019
- 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 cochlear implantation
Who may be able to join
- patients undergoing cochlear implantation in Reims universitary hospital during the inclusion period
- patients who agree to participate in the study
- patients who had preoperative temporal bone CT scan
Who cannot join
- temporal bone malformation on temporal bone CT scan or MRI
- chronic otitis media (except simple middle ear effusion)
- middle ear surgery antecedent
- cochlear implant in the context of a reimplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation
The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.
Read the detailed description
Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.
CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.
Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.
- Conditions
- Cochlear Implantation
- Keywords
- Sensorineural Hearing Loss, Round Window, ear surgery, Cochlear implantation
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cochlear implantation | "cochlear implantation" group : patients undergoing cochlear implantation between December 2018 and June 2019 in the ENT service of Reims universitary hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peroperative round window exposure
peroperative round window exposure evaluated according to St Thomas' Hospital classification:
- visible (classes I and II) and not visible (class III)
- easily visible (classes I and IIa) and not easily visible (class IIb and III)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start18 Dec 2018
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950375
- Sponsor's protocol ID
- PO18155
- Acronym
- R-PO18155
- Status last verified
- Jun 2020
- First submitted
- 13 May 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation
- ClinicalTrials.gov ID
- NCT03950375
- Acronym / sponsor ID
- R-PO18155 / PO18155
- Conditions
- Cochlear Implantation
- Keywords
- Sensorineural Hearing Loss, Round Window, ear surgery, Cochlear implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 15 May 2019 (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 to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.
Detailed description
Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.
CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.
Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cochlear implantation | – | –"cochlear implantation" group : patients undergoing cochlear implantation between December 2018 and June 2019 in the ENT service of Reims universitary hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cochlear implantation
Key inclusion criteria (3 listed)
- patients undergoing cochlear implantation in Reims universitary hospital during the inclusion period
- patients who agree to participate in the study
- patients who had preoperative temporal bone CT scan
Key exclusion criteria (4 listed)
- temporal bone malformation on temporal bone CT scan or MRI
- chronic otitis media (except simple middle ear effusion)
- middle ear surgery antecedent
- cochlear implant in the context of a reimplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peroperative round window exposure
Time frame: Day 0
peroperative round window exposure evaluated according to St Thomas' Hospital classification: * visible (classes I and II) and not visible (class III) * easily visible (classes I and IIa) and not easily visible (class IIb and III)
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 16 Jun 2020.
Related trials for Cochlear Implantation
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
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?
An observational study of Cochlear Implantation, run by CHU de Reims 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 3 inclusion and 4 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 16 Jun 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 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?
peroperative round window exposure (time frame: Day 0). 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 16 Jun 2020.