Tympanostomy Tube InsertionNCT03589209
Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis
An observational study of Tympanostomy Tube Insertion, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery. Read more about this study
- Who is it for?
- Ages 9 months and older
- Conditions the study is for
- Tympanostomy Tube Insertion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 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 9 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
Who may be able to join
- Aged subject from 9 months and over
- Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
- Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.
Who cannot join
- Refusal of the patient to participate in the study
- CROP does not make it possible to evaluate the visibility of the FR
- Preoperative or uninterpretable scanner
- Major anatomical malformation
- Subject under the protection of justice
- Subject under guardianship or curatorship
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
Carine EYERMANN, MD, 33 3 88 12 76 49, Carine.eyermann@chru-strasbourg.fr
About this study
Official title: Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.
The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.
The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.
- Conditions
- Tympanostomy Tube Insertion
- Keywords
- Round window visibility, Cochlear implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)
Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018.
Measured: 1 day after cochlear implantation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 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 Tympanostomy Tube InsertionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CHARPIOT, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589209
- Sponsor's protocol ID
- 7052
- Status last verified
- Jun 2018
- First submitted
- 4 Jul 2018
- Last updated
- 19 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 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT03589209
- Acronym / sponsor ID
- 7052
- Conditions
- Tympanostomy Tube Insertion
- Keywords
- Round window visibility, Cochlear implantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 17 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.
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.
The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.
The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
Key inclusion criteria (3 listed)
- Aged subject from 9 months and over
- Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
- Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.
Key exclusion criteria (6 listed)
- Refusal of the patient to participate in the study
- CROP does not make it possible to evaluate the visibility of the FR
- Preoperative or uninterpretable scanner
- Major anatomical malformation
- Subject under the protection of justice
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 the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)
Time frame: 1 day after cochlear implantation surgery
Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
Anne CHARPIOT, 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 Tympanostomy Tube Insertion, 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 6 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 19 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 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 the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records) (time frame: 1 day after cochlear implantation 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 19 Jul 2018.