Hearing Loss, CochlearNCT04919928
Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids
A study testing Cochlear Implant and Hearing aid in bimodal solution and Bilateral hearing aids in people with Hearing Loss, Cochlear, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Hearing-aid (HA) users with insufficient HA may be better helped with a "Bimodal solution" when replacing the HA with a Cochlear implant (CI) to the poorer hearing ear and a HA to the better hearing ear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Cochlear
- What is being tested?
- Cochlear Implant and Hearing aid in bimodal solution and Bilateral hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 31 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- Adults >18 years old.
- Fluent in Danish, including reading and writing
- Acquired post-lingual deafness
- Use of bilateral HAs for at least one year prior to evaluation for cochlear implantation candidacy. This to ensure, that both ears have received auditive stimulation
- PTA > 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the contralateral ear in best aided condition, in quiet and in noise and in free field.
- SIS <70% in best aided condition in the ear considered for CI implantation and SIS ≥30% and ≤70% in best aided condition in the contralateral ear, in quiet and in noise and in free field.
Who cannot join
- Vestibular loss in the ear not considered for CI implantation
- Surgical issues interfering with the site of implantation or anatomical contraindications such as cochlear malformations, which will be determined using MRI or CT-scans.
- Auditory nerve lesions.
- Central auditory pathway pathologies.
- Otosclerosis.
- Single sided deafness (SSD).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Ear nose and throat department/Hearing-clinic Odense University Hospital
Odense, Southern Denmark, 5000
Yeliz Jakobsen, Medical
About this study
Official title: Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids in Patients With Asymmetric Speech Identification Scores: a Randomised Controlled Trial
Hearing-aid (HA) users with insufficient HA may be better helped with a "Bimodal solution" when replacing the HA with a Cochlear implant (CI) to the poorer hearing ear and a HA to the better hearing ear.
This randomised controlled trial can show the benefit in terms of better speech perception of the bimodal solution with CI to the poorest hearing ear compared to binaural hearing aids.
Read more
It can clarify if HAs users with insufficient HAs benefit will benefit from the bimodal solution when adding a CI to the poorer hearing ear in terms of better speech perception.
It can report the degree of perceived hearing handicap in bimodal CI-users versus bilateral HA-users by hearing -specific patient reported outcome measures (PROM) questionnaires.
And it can contribute to a specific cochlear implant candidacy criterion related to the transition from HA treatment to the CI treatment.
The purpose of this study is to determine if bimodal treatment with a hearing aid to the better hearing ear and CI to the poorer hearing ear increases the ability to understand speech and improve quality of life compared to patients that are treated with hearing aids only.
The benefit of bimodal fittings compared to the best possible bilateral HA treatment will be evaluated.
Read the detailed description
Cochlear implants (CI) have been used to restore hearing in individuals with severe to profound sensorineural hearing loss. Normally, it is required that speech identification scores are below 50% in the ear considered for implantation and that the discrimination in the best-aided condition should be 60% or less. These criteria exclude many patients with asymmetrical hearing, as they have speech identification above 60% in the best-aided condition. It is necessary to investigate how patients with asymmetrical hearing can benefit from a cochlear implant in the poorer hearing ear compared to when bilaterally fitted with HAs. Furthermore, it is still unclear at which clinical relevant candidacy criterion the optimal transition from HA treatment to CI treatment in the bimodal solution occurs, as randomized studies comparing HA users and CI users do not exist. The purpose of this study is to provide clinicians with better evidence to determine if patients who benefit insufficiently from bilateral HA treatment and have a speech discrimination of the better hearing ear > 50% will benefit from a CI in the poorer hearing ear. Patients intended to include in the study will all be adults >18 years with hearing loss on both ears where cochlear implant will be considered as a treatment for the poorest hearing ear. All patients have used hearing aids on both ears for at least 1 year. The benefit of bimodal fittings compared to the best possible bilateral HA treatment is evaluated. Furthermore, it is investigated if this results in increased speech intelligibility and quality of life with a bimodal solution where a cochlear implant is used on the poorer hearing ear compared to either CI alone or bilateral hearing aids. 60 patients referred for cochlear implant at Odense University Hospital will receive new HAs that are fitted for one month. Then they will be randomized to either the intervention group with CI+HA (bimodal) or to the wait and see control group with continuous use of HA+HA (bilateral) for another three months. Participants will undergo stratified randomization depending on the hearing thresholds prior to CI surgery in the poorest hearing ear. To provide better evidence to determine if patients who benefit insufficiently from bilateral Hearing aid treatment and have a speech discrimination of the better hearing ear > 50% will benefit from a Cochlear implant in the poorer hearing ear.
Patients randomized to the intervention group CI+HA will undergo surgery as soon as possible after randomization. The control group that will use the hearing aids for an additional three months, will also be offered the bimodal solution with CI to the poorer hearing ear after total of four months with HA+HA.
Description of the cohort Inclusion criteria - Adults >18 years old. - Fluent in Danish, including reading and writing - Willing to participate in and to comply with all requirements of the protocol. - Post-lingual deafness and use one or two HAs. - Participants should have aidable hearing in the ear not considered for CI implantation - Self-reported HA use of at least eight hour per day for at least one year in both ears prior to evaluation for cochlear implantation in order to ensure, that both ears have received auditive stimulation prior to participation in the study. If possible, the validity of the self-reported hearing aid use will be checked in the HA-log by the audiology assistants. - Participants should have a PTA (0.5,1,2,4 kHz) > 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the ear not considered for implantation. - A speech identification score
Ethics approval for the conduct of this study was obtained from the Ethics Committee Southern Denmark. 21st August 2020.
The trial will be conducted in compliance with this study protocol. All participants will undergo a process of informed consent and will be aware that participation is strictly voluntary.
Participants may withdraw from the study at any time. The project is approved by the Danish Data Protection Agency (file no. 20/22868) in Region South Denmark which is an independent authority that supervises compliance with the rules on protection of personal data. ("paraplyanmeldelse" in danish).
The study statistic analysis plan will be implemented as well.
- Conditions
- Hearing Loss, Cochlear
- Being tested
- Cochlear Implant and Hearing aid in bimodal solution, Bilateral hearing aids
- 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.
Cochlear Implant and Hearing aid in bimodal solutionDevice
Sixty adult participants with bilateral hearing aids (HA) referred for cochlear implantation (CI) will be included in the study. It will be patients who report limited benefit with appropriately fitted HAs in daily speech communication in quiet and in noise. The patients are depending on visual cues for successful communication.
All the referred patients have potential optimal fitted HAs that are no longer sufficient to treat their hearing loss and to improve the daily communication. All the patients will then receive new replacement HAs with the ability to corporate with a CI for one month trial period. One month is considered as a sufficient adaptation period to new replacement HAs according to current clinical practice.
Thirty individuals randomised to receive the intervention with CI to the poorest hearing ear.
Bilateral hearing aidsDevice
Thirty individuals randomised to the control group will continue use of the new replacement HAs another three months, thus in total of four months of use.
| Study group | Role | What they receive |
|---|---|---|
| Bimodal solution with cochlear implant and hearing aid (CI+HA) | Experimental | This Arm will serve as the intervention group. Patients referred for evaluation of cochlear implant candidacy at Odense University Hospital will be screened for eligibility in this study and invited to participate. All patients receive new replacement HAs that can later be fitted with the CI in a bimodal solution. The patients will use the new replacement HAs for one month and are then randomized to either the intervention group with CI+HA or to the control group with continuous use of HA+HA (bilateral) for another two months. Patients randomized to the intervention group CI+HA will undergo surgery as soon as possible after randomization.
Patients with the bimodal solution CI+HA will undergo follow-up one, three, six and twelve months after CI fitting. Receives: Device: Cochlear Implant and Hearing aid in bimodal solution |
| Bilateral new replacement Hearing Aids (HA+HA) | Experimental | This Arm will serve as the control group. The patients in the control group will use the new replacement HAs for one month like the intervention group and then for another three months, if they complete the study. The control group using the new replacement HAs for three months after randomization, will be offered the bimodal solution with CI to the poorer hearing ear and have the same follow-up period as the intervention group after a total of four months with new replacement HAs. Receives: Device: Bilateral hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing in Noise Test (HINT) Speech identification scores
Speech identification scores measured by Hearing in Noise Test (HINT). 1-100% higher is better
Measured: 1 hour
Speech Spatial Questionnaire (SSQ-12)
Patient reported outcomes measured by Speech Spatial Questionnaire (SSQ-12). 1-10, higher is better.
Measured: 1 hour
Secondary outcomes (6)
Dantale I
Speech identification scores measured by Dantale I in quiet and noise in free field at the best aided condition. 1-100%, higher is better
Measured: 1 hour
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Patient reported outcomes measured by Nijmegen Cochlear Implant Questionnaire (NCIQ). 1-100 higher is better
Measured: 1 hour
Tinnitus Handicap Inventory (THI)
Patient reported outcomes measured Tinnitus Handicap Inventory (THI). 1-100, lower is better
Measured: 1 hour
Dizziness Handicap Inventory (DHI) Patient reported outcomes measures
Patient reported outcomes measured Dizziness Handicap Inventory (DHI). 1-100, lower is better.
Measured: 1 hour
Peak pupil dilation (PPD)
Peak pupil dilation measured by pupillometry and HINT, 1-100%, lower is better
Measured: half an hour
Peak-time
Peak-time measured by pupillometry and HINT. 1-10sec, lower is better
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Feb 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper H Schmidt, Consultant, Study director, Ear nose and throat department/Hearing-clinic Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919928
- Sponsor's protocol ID
- 20/22868
- Status last verified
- Nov 2022
- First submitted
- 20 May 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing is described in a Data Management Plan. All Data will be anonymised.
Publications
Jakobsen Y, Christensen Andersen LA, Schmidt JH. Study protocol for a randomised controlled trial evaluating the benefits from bimodal solution with cochlear implant and hearing aid versus bilateral hearing aids in patients with asymmetric speech identification scores. BMJ Open. 2022 Dec 29;12(12):e070296. doi: 10.1136/bmjopen-2022-070296.
PubMed 36581413
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids in Patients With Asymmetric Speech Identification Scores: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04919928
- Acronym / sponsor ID
- 20/22868
- Conditions
- Hearing Loss, Cochlear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Jun 2021 (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.
Hearing-aid (HA) users with insufficient HA may be better helped with a "Bimodal solution" when replacing the HA with a Cochlear implant (CI) to the poorer hearing ear and a HA to the better hearing ear.
This randomised controlled trial can show the benefit in terms of better speech perception of the bimodal solution with CI to the poorest hearing ear compared to binaural hearing aids.
It can clarify if HAs users with insufficient HAs benefit will benefit from the bimodal solution when adding a CI to the poorer hearing ear in terms of better speech perception.
It can report the degree of perceived hearing handicap in bimodal CI-users versus bilateral HA-users by hearing -specific patient reported outcome measures (PROM) questionnaires.
And it can contribute to a specific cochlear implant candidacy criterion related to the transition from HA treatment to the CI treatment.
The purpose of this study is to determine if bimodal treatment with a hearing aid to the better hearing ear and CI to the poorer hearing ear increases the ability to understand speech and improve quality of life compared to patients that are treated with hearing aids only.
The benefit of bimodal fittings compared to the best possible bilateral HA treatment will be evaluated.
Detailed description
Cochlear implants (CI) have been used to restore hearing in individuals with severe to profound sensorineural hearing loss. Normally, it is required that speech identification scores are below 50% in the ear considered for implantation and that the discrimination in the best-aided condition should be 60% or less. These criteria exclude many patients with asymmetrical hearing, as they have speech identification above 60% in the best-aided condition. It is necessary to investigate how patients with asymmetrical hearing can benefit from a cochlear implant in the poorer hearing ear compared to when bilaterally fitted with HAs. Furthermore, it is still unclear at which clinical relevant candidacy criterion the optimal transition from HA treatment to CI treatment in the bimodal solution occurs, as randomized studies comparing HA users and CI users do not exist. The purpose of this study is to provide clinicians with better evidence to determine if patients who benefit insufficiently from bilateral HA treatment and have a speech discrimination of the better hearing ear > 50% will benefit from a CI in the poorer hearing ear. Patients intended to include in the study will all be adults >18 years with hearing loss on both ears where cochlear implant will be considered as a treatment for the poorest hearing ear. All patients have used hearing aids on both ears for at least 1 year. The benefit of bimodal fittings compared to the best possible bilateral HA treatment is evaluated. Furthermore, it is investigated if this results in increased speech intelligibility and quality of life with a bimodal solution where a cochlear implant is used on the poorer hearing ear compared to either CI alone or bilateral hearing aids. 60 patients referred for cochlear implant at Odense University Hospital will receive new HAs that are fitted for one month. Then they will be randomized to either the intervention group with CI+HA (bimodal) or to the wait and see control group with continuous use of HA+HA (bilateral) for another three months. Participants will undergo stratified randomization depending on the hearing thresholds prior to CI surgery in the poorest hearing ear. To provide better evidence to determine if patients who benefit insufficiently from bilateral Hearing aid treatment and have a speech discrimination of the better hearing ear > 50% will benefit from a Cochlear implant in the poorer hearing ear.
Patients randomized to the intervention group CI+HA will undergo surgery as soon as possible after randomization. The control group that will use the hearing aids for an additional three months, will also be offered the bimodal solution with CI to the poorer hearing ear after total of four months with HA+HA.
Description of the cohort Inclusion criteria - Adults >18 years old. - Fluent in Danish, including reading and writing - Willing to participate in and to comply with all requirements of the protocol. - Post-lingual deafness and use one or two HAs. - Participants should have aidable hearing in the ear not considered for CI implantation - Self-reported HA use of at least eight hour per day for at least one year in both ears prior to evaluation for cochlear implantation in order to ensure, that both ears have received auditive stimulation prior to participation in the study. If possible, the validity of the self-reported hearing aid use will be checked in the HA-log by the audiology assistants. - Participants should have a PTA (0.5,1,2,4 kHz) > 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the ear not considered for implantation. - A speech identification score
Ethics approval for the conduct of this study was obtained from the Ethics Committee Southern Denmark. 21st August 2020.
The trial will be conducted in compliance with this study protocol. All participants will undergo a process of informed consent and will be aware that participation is strictly voluntary.
Participants may withdraw from the study at any time. The project is approved by the Danish Data Protection Agency (file no. 20/22868) in Region South Denmark which is an independent authority that supervises compliance with the rules on protection of personal data. ("paraplyanmeldelse" in danish).
The study statistic analysis plan will be implemented as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimodal solution with cochlear implant and hearing aid (CI+HA) | Experimental | Device: Cochlear Implant and Hearing aid in bimodal solutionThis Arm will serve as the intervention group. Patients referred for evaluation of cochlear implant candidacy at Odense University Hospital will be screened for eligibility in this study and invited to participate. All patients receive new replacement HAs that can later be fitted with the CI in a bimodal solution. The patients will use the new replacement HAs for one month and are then randomized to either the intervention group with CI+HA or to the control group with continuous use of HA+HA (bilateral) for another two months. Patients randomized to the intervention group CI+HA will undergo surgery as soon as possible after randomization. Patients with the bimodal solution CI+HA will undergo follow-up one, three, six and twelve months after CI fitting. |
| Bilateral new replacement Hearing Aids (HA+HA) | Experimental | Device: Bilateral hearing aidsThis Arm will serve as the control group. The patients in the control group will use the new replacement HAs for one month like the intervention group and then for another three months, if they complete the study. The control group using the new replacement HAs for three months after randomization, will be offered the bimodal solution with CI to the poorer hearing ear and have the same follow-up period as the intervention group after a total of four months with new replacement HAs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults >18 years old.
- Fluent in Danish, including reading and writing
- Acquired post-lingual deafness
- Use of bilateral HAs for at least one year prior to evaluation for cochlear implantation candidacy. This to ensure, that both ears have received auditive stimulation
- PTA > 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the contralateral ear in best aided condition, in quiet and in noise and in free field.
Key exclusion criteria (6 listed)
- Vestibular loss in the ear not considered for CI implantation
- Surgical issues interfering with the site of implantation or anatomical contraindications such as cochlear malformations, which will be determined using MRI or CT-scans.
- Auditory nerve lesions.
- Central auditory pathway pathologies.
- Otosclerosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Implant and Hearing aid in bimodal solutionSixty adult participants with bilateral hearing aids (HA) referred for cochlear implantation (CI) will be included in the study. It will be patients who report limited benefit with appropriately fitted HAs in daily speech communication in quiet and in noise. The patients are depending on visual cues for successful communication. All the referred patients have potential optimal fitted HAs that are no longer sufficient to treat their hearing loss and to improve the daily communication. All the patients will then receive new replacement HAs with the ability to corporate with a CI for one month trial period. One month is considered as a sufficient adaptation period to new replacement HAs according to current clinical practice. Thirty individuals randomised to receive the intervention with CI to the poorest hearing ear. | Device | Bimodal solution with cochlear implant and hearing aid (CI+HA) |
| Bilateral hearing aidsThirty individuals randomised to the control group will continue use of the new replacement HAs another three months, thus in total of four months of use. | Device | Bilateral new replacement Hearing Aids (HA+HA) |
Primary outcome
Hearing in Noise Test (HINT) Speech identification scores
Time frame: 1 hour
Speech identification scores measured by Hearing in Noise Test (HINT). 1-100% higher is better
Speech Spatial Questionnaire (SSQ-12)
Time frame: 1 hour
Patient reported outcomes measured by Speech Spatial Questionnaire (SSQ-12). 1-10, higher is better.
6 secondary outcomes
Dantale I
Time frame: 1 hour
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time frame: 1 hour
Tinnitus Handicap Inventory (THI)
Time frame: 1 hour
Dizziness Handicap Inventory (DHI) Patient reported outcomes measures
Time frame: 1 hour
Peak pupil dilation (PPD)
Time frame: half an hour
Peak-time
Time frame: half an hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 36581413Jakobsen Y, Christensen Andersen LA, Schmidt JH. Study protocol for a randomised controlled trial evaluating the benefits from bimodal solution with cochlear implant and hearing aid versus bilateral hearing aids in patients with asymmetric speech identification scores. BMJ Open. 2022 Dec 29;12(12):e070296. doi: 10.1136/bmjopen-2022-070296.
- Individual participant dataSharing planned: Yes. The data sharing is described in a Data Management Plan. All Data will be anonymised.
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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.
Jesper H Schmidt, Consultant study director
Ear nose and throat department/Hearing-clinic Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Implant and Hearing aid in bimodal solution and Bilateral hearing aids in people with Hearing Loss, Cochlear, run by University of Southern Denmark at 1 site in Denmark.
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 6 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 22 Nov 2022. 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 Denmark. 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 Yeliz Jakobsen, cand.med. (+4530669135, yeliz.jakobsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing in Noise Test (HINT) Speech identification scores (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919928, which also lists 1 linked publication.
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 22 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.