Hearing Loss, SensorineuralNCT04707885
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
A study testing Electrocochleography in people with Hearing Loss, Sensorineural and Hearing Loss, run by Ohio State University at 5 sites in United States.
Trial summary
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Hearing Loss, Bilateral
- What is being tested?
- Electrocochleography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Nov 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
- Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
- Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
- The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
- Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
Show all 14Show fewer
- Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
- Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
- Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
- Proficient in English.
- Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
- Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
- Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
- Stated willingness and ability to complete testing and all associated study visits.
Who cannot join
- Previous cochlear implantation.
- Prelingual onset of hearing loss.
- Abnormal inner ear anatomy on CT imaging.
- Auditory neuropathy spectrum disorder.
- Retrocochlear pathology such as a vestibular schwannoma or stroke.
- Unwillingness or inability to comply with all investigational requirements including the randomization process.
Show all 9Show fewer
- Additional medical, or social barriers that would prevent completion of all study requirements.
- Medical condition contraindicated for surgery.
- Device selection of Med El CI (per the patient's selection).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Ohio State University Eye and Ear Institute
Columbus, Ohio, 43210
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mayo Clinic
Rochester, Minnesota, 55905
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).
Read the detailed description
The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.
- Being tested
- Electrocochleography
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocochleographyDevice
Also called ECochG
The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component.
For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.
| Study group | Role | What they receive |
|---|---|---|
| ECochG monitoring | Experimental | For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH. Receives: Device: Electrocochleography |
| Control Group | No intervention | For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preservation Advantage
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start10 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Oliver Adunka, Ohio State University
- Investigators
- Oliver Adunka, MD, Principal investigator, Ohio State UniversityAmanda Ortmann, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707885
- Sponsor's protocol ID
- 2020H0477
- Other IDs
- U01DC018920-01
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Eggermont JJ. Ups and Downs in 75 Years of Electrocochleography. Front Syst Neurosci. 2017 Jan 24;11:2. doi: 10.3389/fnsys.2017.00002. eCollection 2017.
PubMed 28174524Gantz BJ, Dunn C, Oleson J, Hansen M, Parkinson A, Turner C. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. 2016 Apr;126(4):962-73. doi: 10.1002/lary.25572. Epub 2016 Jan 12.
PubMed 26756395Gantz BJ, Hansen MR, Turner CW, Oleson JJ, Reiss LA, Parkinson AJ. Hybrid 10 clinical trial: preliminary results. Audiol Neurootol. 2009;14 Suppl 1(Suppl 1):32-8. doi: 10.1159/000206493. Epub 2009 Apr 22.
PubMed 19390173Gautschi-Mills K, Khoza-Shangase K, Pillay D. Preservation of residual hearing after cochlear implant surgery: an exploration of residual hearing function in a group of recipients at cochlear implant units. Braz J Otorhinolaryngol. 2019 May-Jun;85(3):310-318. doi: 10.1016/j.bjorl.2018.02.006. Epub 2018 Mar 24.
PubMed 29631897Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831.
PubMed 20071994Gstoettner WK, Baumgartner WD, Franz P, Hamzavi J. Cochlear implant deep-insertion surgery. Laryngoscope. 1997 Apr;107(4):544-6. doi: 10.1097/00005537-199704000-00022. No abstract available.
PubMed 9111389Gstoettner W, Helbig S, Settevendemie C, Baumann U, Wagenblast J, Arnoldner C. A new electrode for residual hearing preservation in cochlear implantation: first clinical results. Acta Otolaryngol. 2009 Apr;129(4):372-9. doi: 10.1080/00016480802552568.
PubMed 19140036Campbell L, Kaicer A, Sly D, Iseli C, Wei B, Briggs R, O'Leary S. Intraoperative Real-time Cochlear Response Telemetry Predicts Hearing Preservation in Cochlear Implantation. Otol Neurotol. 2016 Apr;37(4):332-8. doi: 10.1097/MAO.0000000000000972.
PubMed 26859542Harris MS, Riggs WJ, Giardina CK, O'Connell BP, Holder JT, Dwyer RT, Koka K, Labadie RF, Fitzpatrick DC, Adunka OF. Patterns Seen During Electrode Insertion Using Intracochlear Electrocochleography Obtained Directly Through a Cochlear Implant. Otol Neurotol. 2017 Dec;38(10):1415-1420. doi: 10.1097/MAO.0000000000001559.
PubMed 28953607Hodges AV, Schloffman J, Balkany T. Conservation of residual hearing with cochlear implantation. Am J Otol. 1997 Mar;18(2):179-83.
PubMed 9093674Koka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385.
PubMed 27879487Lan KK, DeMets DL. Changing frequency of interim analysis in sequential monitoring. Biometrics. 1989 Sep;45(3):1017-20.
PubMed 2790114Pillsbury HC 3rd, Dillon MT, Buchman CA, Staecker H, Prentiss SM, Ruckenstein MJ, Bigelow DC, Telischi FF, Martinez DM, Runge CL, Friedland DR, Blevins NH, Larky JB, Alexiades G, Kaylie DM, Roland PS, Miyamoto RT, Backous DD, Warren FM, El-Kashlan HK, Slager HK, Reyes C, Racey AI, Adunka OF. Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol. 2018 Mar;39(3):299-305. doi: 10.1097/MAO.0000000000001691.
PubMed 29342054Saoji AA, Patel NS, Carlson ML, Neff BA, Koka K, Tarigoppula VSA, Driscoll CLW. Multi-frequency Electrocochleography Measurements can be Used to Monitor and Optimize Electrode Placement During Cochlear Implant Surgery. Otol Neurotol. 2019 Dec;40(10):1287-1291. doi: 10.1097/MAO.0000000000002406.
PubMed 31644474Scheperle RA, Tejani VD, Omtvedt JK, Brown CJ, Abbas PJ, Hansen MR, Gantz BJ, Oleson JJ, Ozanne MV. Delayed changes in auditory status in cochlear implant users with preserved acoustic hearing. Hear Res. 2017 Jul;350:45-57. doi: 10.1016/j.heares.2017.04.005. Epub 2017 Apr 12.
PubMed 28432874
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Residual Hearing in the Cochlear Implant Ear
- ClinicalTrials.gov ID
- NCT04707885
- Acronym / sponsor ID
- 2020H0477
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 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.
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).
Detailed description
The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECochG monitoring | Experimental | Device: ElectrocochleographyFor those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH. |
| Control Group | No intervention | –For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of signed and dated informed consent form.
- Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
- Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
- Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
- Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
Key exclusion criteria (9 listed)
- Previous cochlear implantation.
- Prelingual onset of hearing loss.
- Abnormal inner ear anatomy on CT imaging.
- Auditory neuropathy spectrum disorder.
- Retrocochlear pathology such as a vestibular schwannoma or stroke.
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 |
|---|---|---|
| ElectrocochleographyAlso: ECochGThe use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions. | Device | ECochG monitoring |
Primary outcome
Preservation Advantage
Time frame: 3, 6, 12, 24 months
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 28174524Eggermont JJ. Ups and Downs in 75 Years of Electrocochleography. Front Syst Neurosci. 2017 Jan 24;11:2. doi: 10.3389/fnsys.2017.00002. eCollection 2017.
- Background: PubMed 26756395Gantz BJ, Dunn C, Oleson J, Hansen M, Parkinson A, Turner C. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. 2016 Apr;126(4):962-73. doi: 10.1002/lary.25572. Epub 2016 Jan 12.
- Background: PubMed 19390173Gantz BJ, Hansen MR, Turner CW, Oleson JJ, Reiss LA, Parkinson AJ. Hybrid 10 clinical trial: preliminary results. Audiol Neurootol. 2009;14 Suppl 1(Suppl 1):32-8. doi: 10.1159/000206493. Epub 2009 Apr 22.
- Background: PubMed 29631897Gautschi-Mills K, Khoza-Shangase K, Pillay D. Preservation of residual hearing after cochlear implant surgery: an exploration of residual hearing function in a group of recipients at cochlear implant units. Braz J Otorhinolaryngol. 2019 May-Jun;85(3):310-318. doi: 10.1016/j.bjorl.2018.02.006. Epub 2018 Mar 24.
- Background: PubMed 20071994Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831.
- Background: PubMed 9111389Gstoettner WK, Baumgartner WD, Franz P, Hamzavi J. Cochlear implant deep-insertion surgery. Laryngoscope. 1997 Apr;107(4):544-6. doi: 10.1097/00005537-199704000-00022. No abstract available.
- Background: PubMed 19140036Gstoettner W, Helbig S, Settevendemie C, Baumann U, Wagenblast J, Arnoldner C. A new electrode for residual hearing preservation in cochlear implantation: first clinical results. Acta Otolaryngol. 2009 Apr;129(4):372-9. doi: 10.1080/00016480802552568.
- Background: PubMed 26859542Campbell L, Kaicer A, Sly D, Iseli C, Wei B, Briggs R, O'Leary S. Intraoperative Real-time Cochlear Response Telemetry Predicts Hearing Preservation in Cochlear Implantation. Otol Neurotol. 2016 Apr;37(4):332-8. doi: 10.1097/MAO.0000000000000972.
- Background: PubMed 28953607Harris MS, Riggs WJ, Giardina CK, O'Connell BP, Holder JT, Dwyer RT, Koka K, Labadie RF, Fitzpatrick DC, Adunka OF. Patterns Seen During Electrode Insertion Using Intracochlear Electrocochleography Obtained Directly Through a Cochlear Implant. Otol Neurotol. 2017 Dec;38(10):1415-1420. doi: 10.1097/MAO.0000000000001559.
- Background: PubMed 9093674Hodges AV, Schloffman J, Balkany T. Conservation of residual hearing with cochlear implantation. Am J Otol. 1997 Mar;18(2):179-83.
- Background: PubMed 27879487Koka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385.
- Background: PubMed 2790114Lan KK, DeMets DL. Changing frequency of interim analysis in sequential monitoring. Biometrics. 1989 Sep;45(3):1017-20.
- Individual participant dataSharing planned: No
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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.
Oliver Adunka, MD principal investigator
Ohio State University
Amanda Ortmann, PhD principal investigator
Washington University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocochleography in people with Hearing Loss, Sensorineural and Hearing Loss, run by Ohio State University at 5 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 14 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Preservation Advantage (time frame: 3, 6, 12, 24 months). 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 NCT04707885, which also lists 16 linked publications.
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 20 Oct 2026.