Hearing Loss, High-FrequencyNCT01975571
Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
A study testing Cochlear® Nucleus™ Hybrid L24 and Cochlear® Nucleus™ Hybrid S12 in people with Hearing Loss, High-Frequency, run by Bruce J Gantz at 2 sites in United States.
Trial summary
The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, High-Frequency
- What is being tested?
- Cochlear® Nucleus™ Hybrid L24 and Cochlear® Nucleus™ Hybrid S12
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to 8 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1.1 Criteria for Inclusion in Population 1
- Criterion for selection will be subject interest in preservation of residual hearing; severe sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and realistic expectations. Qualified participants must also meet the following criteria for inclusion:
- Eighteen year of age or older at the time of implantation.
- Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
- Speech Perception:
- The Consonant-Nucleus-Consonant (CNC) word recognition score between 0% and 35% inclusive in the ear to be implanted.
Show all 23Show fewer
- The CNC word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60% in the best-aided condition.
- English spoken as a primary language.
- Willingness to comply with all study requirements.
- Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day).
- Patent cochlea and normal cochlear anatomy.
- 1.2 Criteria for Inclusion in Population 2
- Criterion for selection will be parent interest in preservation of residual hearing; severe post-lingual onset of sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and supportive family dynamics. Qualified participants must also meet the following criteria for inclusion:
- Five to fifteen years of age at the time of implantation.
- Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
- Speech Perception:
- The Phonetically Balanced-Kindergarten (PB-K) word recognition score between 0% and 50% inclusive in the ear to be implanted.
- The PB-K word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60%.
- English spoken as a primary language.
- Willingness to comply with all study requirements.
- Minimum of 30-day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day)..
- Patent cochlea and normal cochlear anatomy.
- Must be in a habilitation/educational program with an emphasis on spoken language development.
Who cannot join
- 1.3 Criteria for Exclusion in Populations 1 and 2
- Medical or psychological conditions that contraindicate undergoing surgery.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
- Active middle ear infection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.
Read the detailed description
The purpose of this study is to determine if individuals with residual low-frequency hearing in the severe range can develop improved speech perception by combining their residual acoustic hearing with electrical processing through a cochlear implant designed to stimulate the high-frequency basal and middle turn of the cochlea while preserving useful low-frequency acoustic hearing. To accomplish this, we propose to implant individuals with severe hearing with a Cochlear® Nucleus™ Hybrid L24 Implant or a Cochlear® Nucleus™ Hybrid S12 in the poorer ear. We believe these devices will do less damage to the Organ of Corti structures, than longer, more invasive standard cochlear implant electrodes.
Two different populations will be studied under this IDE.
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 decibels (dB) hearing level (HL) between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. The potential subject will present with Consonant-Nucleus-Consonant (CNC) monosyllabic word scores between 0-35% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition.
Population 2: 30 Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant or the Cochlear® Nucleus™ Hybrid S12 Implant. Those that have hearing thresholds between 60-90 dB HL at 1500 Hz would be implanted with the less invasive shorter 10 mm Hybrid S12 in attempt to better preserve the middle frequency range. Those with hearing thresholds >90 dB HL at 1500 Hz would receive the longer 16 mm Hybrid L24 electrode. The potential subject will present with Phonetically Balanced Kindergarten (PB-K) monosyllabic word scores between 0-50% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition.
Through the preserved acoustic hearing, we believe the subject will experience better signal to noise ratios for speech perception in noise, better localization of sound and an improvement music perception. Histological evidence from patients implanted with standard arrays and our experience with a short electrode array for implantation of individuals with significant residual hearing both support this assumption (Nadol, Shiao, Burgess, Ketten, Eddington et al., 2001). The duration of this study will be 2 years (24 months) for adults and for 5 years (60 months) in children and adolescents.
- Conditions
- Hearing Loss, High-Frequency
- Being tested
- Cochlear® Nucleus™ Hybrid L24, Cochlear® Nucleus™ Hybrid S12
- Keywords
- residual hearing, hybrid, hearing preservation
- Medical subject headings
- Hearing Loss, High-Frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear® Nucleus™ Hybrid L24Device
The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
Cochlear® Nucleus™ Hybrid S12Device
The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
| Study group | Role | What they receive |
|---|---|---|
| Adult | Experimental | Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant. Receives: Device: Cochlear® Nucleus™ Hybrid L24 |
| Children and adolescents (L24) | Experimental | Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant. Receives: Device: Cochlear® Nucleus™ Hybrid L24 |
| Children and adolescents S12 | Experimental | Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid S12 cochlear implant. Receives: Device: Cochlear® Nucleus™ Hybrid S12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CNC Word Perception
Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted):
Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears)
Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.
Measured: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children
Secondary outcomes (2)
Change in Localization
Pre-operatively and post-operative, testing will be conducted using bilaterally fitted devices (preoperatively) and a cochlear implant and bilateral hearing aids (if applicable) postoperatively (combined condition). Everyday sounds will be presented from one of eight loudspeakers at 60 dBA forming a 108- arc. The participant will face the center of the speaker array at a 1.4 m. 16 different sounds will be repeated 6 times and presented randomly from one of the loudspeakers. Localization performance was calculated by the average root-mean-square (RMS) error in degrees.
Measured: Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children
AzBio +5 Noise
Sentences in a +5 dB noise will be administered. Sentences will be tested at 60 dB(A) and noise at 55 dB(A) from the front. Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) The AzBio sentence perception test consists of multiple lists of 20 sentences that are presented in sound-field from a loudspeaker using an open set format. Percent correct is calculated by the number of words correctly identified by the subject out of the total number of words presented in the sentence lists.
Measured: Adults pre-op, 3, 6, 12, 24 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJul 2011
- Primary completion8 Sep 2018
- Study completion8 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, High-FrequencyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce J Gantz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruce J Gantz, University of Iowa
- Investigators
- Bruce Gantz, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975571
- Sponsor's protocol ID
- 201106758
- Status last verified
- May 2022
- First submitted
- 6 Jul 2012
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
- ClinicalTrials.gov ID
- NCT01975571
- Acronym / sponsor ID
- 201106758
- Conditions
- Hearing Loss, High-Frequency
- Keywords
- residual hearing, hybrid, hearing preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bruce J GantzUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 8 Sep 2018 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Posted 8 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.
Detailed description
The purpose of this study is to determine if individuals with residual low-frequency hearing in the severe range can develop improved speech perception by combining their residual acoustic hearing with electrical processing through a cochlear implant designed to stimulate the high-frequency basal and middle turn of the cochlea while preserving useful low-frequency acoustic hearing. To accomplish this, we propose to implant individuals with severe hearing with a Cochlear® Nucleus™ Hybrid L24 Implant or a Cochlear® Nucleus™ Hybrid S12 in the poorer ear. We believe these devices will do less damage to the Organ of Corti structures, than longer, more invasive standard cochlear implant electrodes.
Two different populations will be studied under this IDE.
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 decibels (dB) hearing level (HL) between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. The potential subject will present with Consonant-Nucleus-Consonant (CNC) monosyllabic word scores between 0-35% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition.
Population 2: 30 Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant or the Cochlear® Nucleus™ Hybrid S12 Implant. Those that have hearing thresholds between 60-90 dB HL at 1500 Hz would be implanted with the less invasive shorter 10 mm Hybrid S12 in attempt to better preserve the middle frequency range. Those with hearing thresholds >90 dB HL at 1500 Hz would receive the longer 16 mm Hybrid L24 electrode. The potential subject will present with Phonetically Balanced Kindergarten (PB-K) monosyllabic word scores between 0-50% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition.
Through the preserved acoustic hearing, we believe the subject will experience better signal to noise ratios for speech perception in noise, better localization of sound and an improvement music perception. Histological evidence from patients implanted with standard arrays and our experience with a short electrode array for implantation of individuals with significant residual hearing both support this assumption (Nadol, Shiao, Burgess, Ketten, Eddington et al., 2001). The duration of this study will be 2 years (24 months) for adults and for 5 years (60 months) in children and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult | Experimental | Device: Cochlear® Nucleus™ Hybrid L24Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant. |
| Children and adolescents (L24) | Experimental | Device: Cochlear® Nucleus™ Hybrid L24Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant. |
| Children and adolescents S12 | Experimental | Device: Cochlear® Nucleus™ Hybrid S12Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid S12 cochlear implant. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- 1.1 Criteria for Inclusion in Population 1
- Criterion for selection will be subject interest in preservation of residual hearing; severe sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and realistic expectations. Qualified participants must also meet the following criteria for inclusion:
- Eighteen year of age or older at the time of implantation.
- Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
- Speech Perception:
Key exclusion criteria (6 listed)
- 1.3 Criteria for Exclusion in Populations 1 and 2
- Medical or psychological conditions that contraindicate undergoing surgery.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
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® Nucleus™ Hybrid L24The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne. | Device | Adult, Children and adolescents (L24) |
| Cochlear® Nucleus™ Hybrid S12The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy. | Device | Children and adolescents S12 |
Primary outcome
Change in CNC Word Perception
Time frame: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children
Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.
2 secondary outcomes
Change in Localization
Time frame: Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children
AzBio +5 Noise
Time frame: Adults pre-op, 3, 6, 12, 24 months post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Bruce Gantz, MD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear® Nucleus™ Hybrid L24 and Cochlear® Nucleus™ Hybrid S12 in people with Hearing Loss, High-Frequency, run by Bruce J Gantz at 2 sites in United States.
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 23 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CNC Word Perception (time frame: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children). 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 8 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.