Conductive Hearing LossNCT02304692

Clinical Survey of Different Abutment Topologies

A study testing Bone anchored hearing aid in people with Conductive Hearing Loss and Unilateral Partial Deafness, run by Oticon Medical at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss
What is being tested?: Bone anchored hearing aid
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteSweden
Study dates: Oct 2014to Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Any adult (18 years of age or older) patient eligible for a bone anchored hearing system

Who cannot join

Inability or unwillingness to participate in follow-up
Skin thickness of > 10 mm
Diseases known to compromise bone quality
Irradiated in the implant area

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of Otorhinolaryngology, Karolinska University Hospital
Stockholm, 171 76

Other trials in Sweden

About this study

Official title: C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems

This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.

Conditions: Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss
Being tested: Bone anchored hearing aid
Medical subject headings: Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone anchored hearing aidDevice
Also called BAHS, BAHA

Study groups in NCT02304692
Study group	Role	What they receive
Oticon Medical Machined Abutment	Sham comparator	A non surface modified abutment is used Receives: Device: Bone anchored hearing aid
Oticon Medical Modified Abutment	Experimental	A surface modified abutment is used Receives: Device: Bone anchored hearing aid

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of colony forming units (CFU)
The primary end point is CFU counts 3 months post-surgery.
Measured: 3 months post-surgery

Secondary outcomes (14)

Number of colony forming units (CFU) on abutment (CFU/abutment)
Measured: 3 months post-surgery
Number of colony forming units (CFU) on abutment (CFU/abutment)
Measured: 12 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Measured: 3 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Measured: 12 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Measured: 3 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Measured: 12 months post-surgery
RNA level for host inflammatory response
Measured: 3 months post-surgery
RNA level for tissue repair
Measured: 3 months post-surgery
RNA level for host host microbial infection response
Measured: 3 months post-surgery
RNA level for host inflammatory response
Measured: 12 months post-surgery
RNA level for tissue repair
Measured: 12 months post-surgery
RNA level for host host microbial infection response
Measured: 12 months post-surgery
Histology investigation of tissue biopsy
Measured: 3 months post-surgery
Histology investigation of tissue biopsy
Measured: 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Dec 2017

First posted2 Dec 2014 (estimated)
Study startOct 2014
Primary completionMar 2016
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02304692
Sponsor's protocol ID: C49
Status last verified: Feb 2018
First submitted: 14 Nov 2014
Last updated: 22 Feb 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Recruiting
Evaluation of Flexible Conductive Hearing Aids
Conductive Hearing Loss
RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Bone Conduction, Hearing Loss, Conductive

All Conductive Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems
ClinicalTrials.gov ID: NCT02304692
Acronym / sponsor ID: C49
Conditions: Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (estimated)
Lead sponsor: Oticon MedicalIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Mar 2016 (actual)
Study completion: Dec 2017 (actual)
First posted: 2 Dec 2014 (estimated)
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.

This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oticon Medical Machined Abutment	Sham comparator	Device: Bone anchored hearing aidA non surface modified abutment is used
Oticon Medical Modified Abutment	Experimental	Device: Bone anchored hearing aidA surface modified abutment is used

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Any adult (18 years of age or older) patient eligible for a bone anchored hearing system

Key exclusion criteria (4 listed)

Inability or unwillingness to participate in follow-up
Skin thickness of > 10 mm
Diseases known to compromise bone quality
Irradiated in the implant area

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
Bone anchored hearing aidAlso: BAHS, BAHA	Device	Oticon Medical Machined Abutment, Oticon Medical Modified Abutment

Primary outcome

Number of colony forming units (CFU)
Time frame: 3 months post-surgery
The primary end point is CFU counts 3 months post-surgery.

14 secondary outcomes

Number of colony forming units (CFU) on abutment (CFU/abutment)
Time frame: 3 months post-surgery
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time frame: 12 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Time frame: 3 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Time frame: 12 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time frame: 3 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time frame: 12 months post-surgery
RNA level for host inflammatory response
Time frame: 3 months post-surgery
RNA level for tissue repair
Time frame: 3 months post-surgery
RNA level for host host microbial infection response
Time frame: 3 months post-surgery
RNA level for host inflammatory response
Time frame: 12 months post-surgery
RNA level for tissue repair
Time frame: 12 months post-surgery
RNA level for host host microbial infection response
Time frame: 12 months post-surgery
Histology investigation of tissue biopsy
Time frame: 3 months post-surgery
Histology investigation of tissue biopsy
Time frame: 12 months post-surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.

Related trials for Conductive Hearing Loss

Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Recruiting
Evaluation of Flexible Conductive Hearing Aids
Conductive Hearing Loss
RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Bone Conduction, Hearing Loss, Conductive

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.

Sofia Jonhede study chair

Sponsor GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bone anchored hearing aid in people with Conductive Hearing Loss and Unilateral Partial Deafness, run by Oticon Medical at 1 site in Sweden.

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 1 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of colony forming units (CFU) (time frame: 3 months post-surgery). 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 NCT02304692.

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 22 Feb 2018.