Perilymphatic FistulasNCT03543293
Imaging Perilymphatic Fistulas After Barotrauma
An observational study of Perilymphatic Fistulas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perilymphatic Fistulas
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2018to Feb 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: Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)
Who may be able to join
- Age greater than or equal to 18
- Clinical suspicion of perilymphatic fistula
- Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)
Who cannot join
- Refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Imagerie 1
Strasbourg, 67098
Francis VEILLON, MD, PhD, 33 3 88 12 78 65
Aïna VENKATASAMY, MD, 33 3 88 12 78 65, aina.venkatasamy@chru-strasbourg.fr
About this study
Official title: Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation
Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.
- Conditions
- Perilymphatic Fistulas
- Keywords
- perilymphatic fistulas, magnetic resonance imaging (MRI), surgery, round window, vertigo, tinnitus, cophosis
- Medical subject headings
- Vertigo, Tinnitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of perilymphatic fistula
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start20 Feb 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perilymphatic FistulasStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis VEILLON, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543293
- Sponsor's protocol ID
- 6807
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation
- ClinicalTrials.gov ID
- NCT03543293
- Acronym / sponsor ID
- 6807
- Conditions
- Perilymphatic Fistulas
- Keywords
- perilymphatic fistulas, magnetic resonance imaging (MRI), surgery, round window, vertigo, tinnitus, cophosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Jun 2018 (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.
Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)
Key inclusion criteria (3 listed)
- Age greater than or equal to 18
- Clinical suspicion of perilymphatic fistula
- Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)
Key exclusion criteria (1 listed)
- Refusal of the patient to participate in the study
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
Diagnosis of perilymphatic fistula
Time frame: 1 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
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.
Francis VEILLON, MD, PhD study director
University Hospital, Strasbourg, France
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 Perilymphatic Fistulas, run by University Hospital, Strasbourg, 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 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: status not confirmed, as of the sponsor's last update on 1 Jun 2018. 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 Francis VEILLON, MD, PhD (33 3 88 12 78 65, Francis.veillon@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of perilymphatic fistula (time frame: 1 hour after surgery). 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 1 Jun 2018.