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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03086135




Registration number
NCT03086135
Ethics application status
Date submitted
9/03/2017
Date registered
22/03/2017

Titles & IDs
Public title
Clinical Performance of a New Implant System for Bone Conduction Hearing
Scientific title
Clinical Performance of a New Implant System for Bone Conduction Hearing
Secondary ID [1] 0 0
CBAS5539
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deafness; Sensoneural Single Sided 0 0
Conductive Hearing Loss 0 0
Mixed Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Osia System

Experimental: Bone-conduction hearing device - The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.


Treatment: Devices: Osia System
An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
Timepoint [1] 0 0
Baseline before surgery, 3 months after surgery
Primary outcome [2] 0 0
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
Timepoint [2] 0 0
Baseline before surgery, 3 months after surgery
Secondary outcome [1] 0 0
Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
Timepoint [1] 0 0
Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Secondary outcome [2] 0 0
Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
Timepoint [2] 0 0
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Secondary outcome [3] 0 0
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
Timepoint [3] 0 0
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Secondary outcome [4] 0 0
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
Timepoint [4] 0 0
Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Secondary outcome [5] 0 0
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
Timepoint [5] 0 0
Baseline before surgery, 3 and 12 months after surgery
Secondary outcome [6] 0 0
Health Utility Index (HUI) at 3 and 12 Months
Timepoint [6] 0 0
Baseline before surgery and 3 and 12 months after surgery
Secondary outcome [7] 0 0
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
Timepoint [7] 0 0
Baseline before surgery and 3 and 12 months after surgery
Secondary outcome [8] 0 0
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
Timepoint [8] 0 0
Baseline before surgery, 4 weeks, 3, 6 and 12 months.
Secondary outcome [9] 0 0
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
Timepoint [9] 0 0
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Secondary outcome [10] 0 0
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
Timepoint [10] 0 0
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Secondary outcome [11] 0 0
Adaptive Speech Recognition in Noise, With Reference Device BP110
Timepoint [11] 0 0
Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Secondary outcome [12] 0 0
Surgical Information: Time of Surgery
Timepoint [12] 0 0
Visit 2, surgery
Secondary outcome [13] 0 0
Soft Tissue Thickness
Timepoint [13] 0 0
Visit 2, surgery
Secondary outcome [14] 0 0
Soft Tissue Reduction
Timepoint [14] 0 0
Visit 2, surgery
Secondary outcome [15] 0 0
Bone Polishing/Removal at Implant Site
Timepoint [15] 0 0
Visit 2, surgery
Secondary outcome [16] 0 0
Type of Anaesthesia
Timepoint [16] 0 0
Visit 2, surgery
Secondary outcome [17] 0 0
Location of BI300 Implant
Timepoint [17] 0 0
Visit 2, surgery
Secondary outcome [18] 0 0
Incision Type
Timepoint [18] 0 0
Visit 2, surgery
Secondary outcome [19] 0 0
Daily Usage Time of Sound Processor
Timepoint [19] 0 0
6 weeks, 3, 6 and 12 months
Secondary outcome [20] 0 0
Comfort
Timepoint [20] 0 0
6 weeks, 3, 6 and 12 months
Secondary outcome [21] 0 0
Magnet Choice
Timepoint [21] 0 0
4, 6 weeks, 3, 6 and 12 months
Secondary outcome [22] 0 0
Softpad Use
Timepoint [22] 0 0
6 weeks, 3, 6 and 12 months

Eligibility
Key inclusion criteria
* Adult subjects (18 years or older)
* Subject with conductive 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 HL.

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

* Signed informed consent
* Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 for implantation of a BI300 Implant.
* Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
* 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.
* Participation in another clinical investigation with pharmaceutical and/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
9/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2019
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
VIC 3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Württemberg
Country [3] 0 0
Netherlands
State/province [3] 0 0
Nijmegen
Country [4] 0 0
Poland
State/province [4] 0 0
Nadarzyn

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Emmanuel Mylanus, Prof.
Address 0 0
Radboud Univerity Medical centre
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/NCT03086135