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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04754477




Registration number
NCT04754477
Ethics application status
Date submitted
10/02/2021
Date registered
15/02/2021

Titles & IDs
Public title
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Scientific title
A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
Secondary ID [1] 0 0
CBAS5793
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Active Osseointegrated Steady-State Implant System (OSI)

Experimental: Active Osseointegrated Steady-State Implant System (OSI) -


Treatment: Devices: Active Osseointegrated Steady-State Implant System (OSI)
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and Type of Reported Adverse Events
Timepoint [1] 0 0
6 months post-surgery to 24 months post-surgery
Primary outcome [2] 0 0
Number and Type of Reported Device Deficiencies
Timepoint [2] 0 0
6 months post-surgery to 24 months post-surgery
Primary outcome [3] 0 0
Concomitant Medication Used
Timepoint [3] 0 0
6 months post-surgery to 24 months post-surgery
Primary outcome [4] 0 0
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Timepoint [4] 0 0
12 months post-surgery
Primary outcome [5] 0 0
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Timepoint [5] 0 0
24 months post-surgery
Primary outcome [6] 0 0
Change in Audiometric Thresholds With the Active Osseointegrated Steady-State Implant System at 12 Months Post-surgery and 24 Months Post-surgery Compared to Preoperative Thresholds Via an Audiogram
Timepoint [6] 0 0
Baseline before surgery, 12 months and 24 months post-surgery
Secondary outcome [1] 0 0
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 Months and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
Timepoint [1] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [2] 0 0
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds
Timepoint [2] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [3] 0 0
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Adaptive Speech Recognition in Noise
Timepoint [3] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [4] 0 0
Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Bone Conduction (BC) Direct
Timepoint [4] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [5] 0 0
Difference in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [5] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [6] 0 0
Change in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [6] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [7] 0 0
Change in Health-related Quality of Life With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [7] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [8] 0 0
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Timepoint [8] 0 0
12 months post-surgery
Secondary outcome [9] 0 0
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Timepoint [9] 0 0
12 months post-surgery
Secondary outcome [10] 0 0
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Timepoint [10] 0 0
12 months post-surgery
Secondary outcome [11] 0 0
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Timepoint [11] 0 0
12 months post-surgery
Secondary outcome [12] 0 0
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Timepoint [12] 0 0
24 months post-surgery
Secondary outcome [13] 0 0
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Timepoint [13] 0 0
24 months post-surgery
Secondary outcome [14] 0 0
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Timepoint [14] 0 0
24 months post-surgery
Secondary outcome [15] 0 0
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Timepoint [15] 0 0
24 months post-surgery
Secondary outcome [16] 0 0
Daily Use of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [16] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [17] 0 0
Daily Streaming Time of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [17] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [18] 0 0
Battery Lifetime of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [18] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [19] 0 0
Magnet Choice of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [19] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [20] 0 0
Use of SoftWear Pad for the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [20] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [21] 0 0
Retention of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [21] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery
Secondary outcome [22] 0 0
Wearing Comfort of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study
Timepoint [22] 0 0
3 or 6 months post-surgery, 12 and 24 months post-surgery

Eligibility
Key inclusion criteria
* Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
* Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2022
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
SCIC / NextSense - Gladesville
Recruitment hospital [2] 0 0
HEARnet Clinical studies - Carlton
Recruitment postcode(s) [1] 0 0
2111 - Gladesville
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Statistiska Konsultgruppen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karin Ganlöv, MD
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04754477