Trial · NCT06598059
Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array
NCT06598059, Not applicable, Active not recruiting, Cochlear
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array. Trials, record NCT06598059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06598059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array
- NCT number
- NCT06598059
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 56 participants, actual
- Lead sponsor
- Cochlear
- Conditions
- Hearing Loss
- Interventions
- Cochlear implant, Dexamethasone
- First posted
- 2024-09-19
- Last updated
- 2026-03-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation | On day of implantation and at 1- and 3-months postactivation | Impedance will be measured across the active electrodes of the implant for each participant. |
| Primary | Coprimary endpoint 2: Mean change in word recognition score in the best unilateral listening mode in quiet from preimplantation to 3 months postactivation | Preoperative baseline and 3-months postactivation | Within-subject change in consonant-nucleus-consonant (CNC) words in quiet (% correct) calculated as the average across 2 runs of the test conducted on each participant. CNC word score ranges from 0-100%, higher the score the better the outcome. |
| Secondary | Mean within-subject change in the global score of the Speech, Spatial, and Qualities of hearing scale (SSQ12) from preimplantation to postimplantation | Preoperative baseline and 6-months postactivation | Within-subject change in Global SSQ12 scores at 6-months postactivation compared with preoperative baseline. The global SSQ12 score ranges from 0-10, higher the score the better the outcome. |
| Secondary | Mean within-subject change in sentence recognition score in the best unilateral listening mode in noise from preimplantation to postimplantation | Preoperative baseline and 6-months postactivation | Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome. |
| Secondary | Mean within-subject change in sentence recognition score in the best bilateral listening mode in noise from preimplantation to postimplantation | Preoperative baseline and 6-months postactivation | Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome. |
| Other | Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency throughout the study | From implantation to 12-months postimplantation (study end) | Adverse events will be recorded as overall, by severity, by relatedness to device or procedure, or by seriousness. Device deficiency will be recorded as overall and by type. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06598059
GET https://conductscience.org/api/trials/v1/NCT06598059/registered