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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04041700




Registration number
NCT04041700
Ethics application status
Date submitted
30/07/2019
Date registered
1/08/2019

Titles & IDs
Public title
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Scientific title
A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
Secondary ID [1] 0 0
CBAS5751
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 - Osia 2 system

Experimental: Osia 2 system -


Treatment: Devices: Osia 2 system
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 processor.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
Timepoint [1] 0 0
Baseline before surgery, 3 months after surgery
Primary outcome [2] 0 0
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Timepoint [2] 0 0
Baseline before surgery, 3 months after surgery
Secondary outcome [1] 0 0
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Timepoint [1] 0 0
Baseline before surgery, 4 weeks and 6 months after surgery
Secondary outcome [2] 0 0
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Timepoint [2] 0 0
Baseline before surgery, 4 weeks and 6 months after surgery
Secondary outcome [3] 0 0
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Timepoint [3] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary outcome [4] 0 0
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet
Timepoint [4] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary outcome [5] 0 0
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Timepoint [5] 0 0
Baseline before surgery, 3 months and 6 months after surgery
Secondary outcome [6] 0 0
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire
Timepoint [6] 0 0
Baseline before surgery, 3 months and 6 months after surgery
Secondary outcome [7] 0 0
Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire
Timepoint [7] 0 0
Baseline before surgery, 3 months and 6 months after surgery
Secondary outcome [8] 0 0
Surgical Information: Soft Tissue Thickness
Timepoint [8] 0 0
Baseline before surgery or at surgery
Secondary outcome [9] 0 0
Surgical Information: Surgery Time
Timepoint [9] 0 0
At surgery
Secondary outcome [10] 0 0
Surgical Information: Bone Polishing/Removal at the Actuator Site
Timepoint [10] 0 0
At surgery
Secondary outcome [11] 0 0
Surgical Information: BI300 Implant Length
Timepoint [11] 0 0
At surgery
Secondary outcome [12] 0 0
Surgical Information: Location of BI300 Implant
Timepoint [12] 0 0
At surgery
Secondary outcome [13] 0 0
Surgical Information: Type of Anesthesia
Timepoint [13] 0 0
At surgery
Secondary outcome [14] 0 0
Surgical Information: Soft Tissue Reduction
Timepoint [14] 0 0
At surgery
Secondary outcome [15] 0 0
Surgical Information: Surgical Incision Type
Timepoint [15] 0 0
At surgery
Secondary outcome [16] 0 0
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Timepoint [16] 0 0
At surgery
Secondary outcome [17] 0 0
Surgical Information: Estimated Length of the Surgical Incision
Timepoint [17] 0 0
At surgery
Secondary outcome [18] 0 0
Surgical Information: Placement of the Coil
Timepoint [18] 0 0
At surgery
Secondary outcome [19] 0 0
Usability Information: Magnet Choice
Timepoint [19] 0 0
At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [20] 0 0
Usability Information: Sound Processor Retention
Timepoint [20] 0 0
At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [21] 0 0
Usability Information: Sound Processor Wearing Comfort
Timepoint [21] 0 0
At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [22] 0 0
Usability Information: Use of SoftWear Pad
Timepoint [22] 0 0
At 6 weeks, 3 months and 6 months after surgery
Secondary outcome [23] 0 0
Usability Information: Daily Use of Sound Processor
Timepoint [23] 0 0
At 6 weeks, 3 months and 6 months after surgery
Secondary outcome [24] 0 0
Usability Information: Daily Streaming Time of Sound Processor
Timepoint [24] 0 0
At 6 weeks, 3 months and 6 months after surgery
Secondary outcome [25] 0 0
Usability Information: Battery Lifetime of Sound Processor
Timepoint [25] 0 0
At 6 weeks, 3 months and 6 months after surgery
Secondary outcome [26] 0 0
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Timepoint [26] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary outcome [27] 0 0
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Timepoint [27] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary outcome [28] 0 0
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise
Timepoint [28] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary outcome [29] 0 0
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet
Timepoint [29] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary outcome [30] 0 0
Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct
Timepoint [30] 0 0
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

Eligibility
Key inclusion criteria
* Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of = 55 dB sensorineural hearing loss.

OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of = 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.

* Adult subjects (18 years or older).
* Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
* Candidate is a fluent speaker in the language used to assess speech perception performance.
* 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
* Uncontrolled diabetes as judged by the investigator.
* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
* Insufficient bone quality and quantity to support successful implant placement.
* Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
* 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.
* Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
* Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.

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
16/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/09/2020
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Cochlear Implant Centre - Gladesville
Recruitment hospital [2] 0 0
The Royal Victorian Eye and Ear Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Gladesville
Recruitment postcode(s) [2] 0 0
- Melbourne
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
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


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/NCT04041700