Reconstruction of the Posterior Membranous LabyrinthNCT03295929
3D Model of Posterior Membranous Labyrinth of the Inner Ear
An observational study of Reconstruction of the Posterior Membranous Labyrinth, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reconstruction of the Posterior Membranous Labyrinth
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2017to Sep 2018
- 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
- Adult, Older adult
Study population: Adult who has performed an imaging of the inner ear
Who may be able to join
- Patient aged 18 or over
- Adult who has performed an imaging of the inner ear
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Orl Et de Chirurgie Cervico-Faciale
Strasbourg, 67091
Anne CHARPIOT, MD, PhD, 33 3 88 12 76 49, anne.charpiot@chru-strasbourg.fr
Hella VUONG, MD, 33 6 50 66 82 23, hella.vuong@chru-strasbourg.fr
About this study
Official title: 3D Finite Element Model of Posterior Membranous Labyrinth From in Vivo MRI of Human Temporal Bone
The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical studies of vestibular physiology.
- Keywords
- 3D model, Inner ear
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of dimensions of the model to study the validity of the geometry
Measured: Creation of 3D model: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start19 Oct 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of the Posterior Membranous LabyrinthStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 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
- NCT03295929
- Sponsor's protocol ID
- 6815
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 27 Feb 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 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Finite Element Model of Posterior Membranous Labyrinth From in Vivo MRI of Human Temporal Bone
- ClinicalTrials.gov ID
- NCT03295929
- Acronym / sponsor ID
- 6815
- Keywords
- 3D model, Inner ear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 28 Sep 2017 (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 this work is to create a three-dimensional (3D) finite element model (FEM) of the human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical studies of vestibular physiology.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult who has performed an imaging of the inner ear
Key inclusion criteria (2 listed)
- Patient aged 18 or over
- Adult who has performed an imaging of the inner ear
Key exclusion criteria (1 listed)
- Refusal 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
Measure of dimensions of the model to study the validity of the geometry
Time frame: Creation of 3D model: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
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 Reconstruction of the Posterior Membranous Labyrinth, 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 2 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 27 Feb 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 Anne CHARPIOT, MD, PhD (33 3 88 12 76 49, anne.charpiot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of dimensions of the model to study the validity of the geometry (time frame: Creation of 3D model: 1 month). 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 27 Feb 2018.