Hydrops SaccularNCT03581396
Scleral Hydrops and Intralabyrinthine Schwannoma
An observational study of Hydrops Saccular, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrops Saccular
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2018to Jun 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 having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017
Who may be able to join
- Age> 18,
- Subject having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017
- Presence on the MRI of the internal auditory ducts, including the realization of a high resolution fluid sequence of FIESTA-C (exploitable) type, of an intralabyrinthine schwannoma, without extension to the internal auditory canal.
- Subject who has agreed to the use of medical data for the purposes of this research.
- Criteria for Non Inclusion
- Refusal of the patient to participate in the study
Show all 13Show fewer
- Absence of high resolution fluid sequence of fast imaging employing steady state acquisition (FIESTA-C)
- Presence of movement artifacts interfering with the interpretation of the FIESTA-C sequence
- Interior surgery of the inner ear or pontocerebellar angle, without preoperative imaging Inflammatory or infectious pathology of the concomitant middle or inner ear
- Extension of schwannoma to the internal auditory canal
- Impossibility of giving the subject informed information (difficulty understanding the subject,)
- Subject under the protection of justice
- Subject under guardianship or curatorship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Imagerie 1
Strasbourg, 67091
Aïna VENKATASAMY, MD, 33 3 88 12 78 65, aina.venkatasamy@chru-strasbourg.fr
Pauline BRETZ, MD, 33 3 88 12 78 65, paulinebretz@hotmail.com
About this study
The symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops.
Some publications have described dilatation of the membranous labyrinth (hydrops) in the presence of intralabyrinthine tumors.
It would be interesting to measure the size of the saccule (structure of the membranous labyrinth) in the presence of an intralabyrinthine schwannoma, to evaluate if some of the symptoms presented by the patients could be explained by the concomitant presence of an endolymphatic hydrops (accessible to drug therapy - Betahistine).
- Conditions
- Hydrops Saccular
- Keywords
- Hydrops sacculaire, schwannoma intralabyrinth
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of intralabyrinth saccules
To measure saccule size (membranous labyrinth structure) in patients with intralabyrinthine schwannoma on a high resolution fluid sequence (FIESTA-C) in 3T MRI
Measured: 1 hour after the realization of the MRI]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start22 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrops SaccularStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581396
- Sponsor's protocol ID
- 7026
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Hydrops and Intralabyrinthine Schwannoma
- ClinicalTrials.gov ID
- NCT03581396
- Acronym / sponsor ID
- 7026
- Conditions
- Hydrops Saccular
- Keywords
- Hydrops sacculaire, schwannoma intralabyrinth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 10 Jul 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.
The symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops.
Some publications have described dilatation of the membranous labyrinth (hydrops) in the presence of intralabyrinthine tumors.
It would be interesting to measure the size of the saccule (structure of the membranous labyrinth) in the presence of an intralabyrinthine schwannoma, to evaluate if some of the symptoms presented by the patients could be explained by the concomitant presence of an endolymphatic hydrops (accessible to drug therapy - Betahistine).
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
- Patients having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017
Key inclusion criteria (13 listed)
- Age> 18,
- Subject having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017
- Presence on the MRI of the internal auditory ducts, including the realization of a high resolution fluid sequence of FIESTA-C (exploitable) type, of an intralabyrinthine schwannoma, without extension to the internal auditory canal.
- Subject who has agreed to the use of medical data for the purposes of this research.
- Criteria for Non Inclusion
Key exclusion criteria (0 listed)
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
Size of intralabyrinth saccules
Time frame: 1 hour after the realization of the MRI]
To measure saccule size (membranous labyrinth structure) in patients with intralabyrinthine schwannoma on a high resolution fluid sequence (FIESTA-C) in 3T MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
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.
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 Hydrops Saccular, 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 13 inclusion and 0 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 10 Jul 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 Aïna VENKATASAMY,, MD (33 3 88 12 78 65, aina.venkatasamy@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of intralabyrinth saccules (time frame: 1 hour after the realization of the MRI]). 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 10 Jul 2018.