Conductive Hearing LossNCT02274129
Clinical Survey of Oticon Medical Healing Cap
A study testing Healing cap II in people with Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 2 sites in Denmark.
Trial summary
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness
- What is being tested?
- Healing cap II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2014to 19 Apr 2016
- 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
- Patients eligible for treatment with a bone anchored hearing aid
- 18 years or older
Who cannot join
- Inability to participate in follow-up
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital
Aalborg, 9000
Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet
Gentofte Municipality, Hellerup, 2900
About this study
Official title: C51 - Clinical Survey of Oticon Medical Healing Cap
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
Read the detailed description
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.
- Being tested
- Healing cap II
- 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.
Healing cap IIDevice
Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Use of Healing cap II | Experimental | Single arm study using a new healing cap as intervention Receives: Device: Healing cap II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin reactions according to Holgers
Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.
Measured: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Secondary outcomes (1)
Fitting of sound processor at surgical follow-up visit
Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.
Measured: At time of surgical follow up visit (visit window of 7-14 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completion19 Apr 2016
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Søren Foghsgaard, M.D., Principal investigator, Soeren.Foghsgaard@regionh.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274129
- Sponsor's protocol ID
- C51
- Status last verified
- Nov 2017
- First submitted
- 14 Oct 2014
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C51 - Clinical Survey of Oticon Medical Healing Cap
- ClinicalTrials.gov ID
- NCT02274129
- Acronym / sponsor ID
- C51
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 19 Apr 2016 (actual)
- First posted
- 24 Oct 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 investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
Detailed description
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Healing cap II | Experimental | Device: Healing cap IISingle arm study using a new healing cap as intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients eligible for treatment with a bone anchored hearing aid
- 18 years or older
Key exclusion criteria (2 listed)
- Inability to participate in follow-up
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
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 |
|---|---|---|
| Healing cap IIHealing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery | Device | Use of Healing cap II |
Primary outcome
Skin reactions according to Holgers
Time frame: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.
1 secondary outcome
Fitting of sound processor at surgical follow-up visit
Time frame: At time of surgical follow up visit (visit window of 7-14 days after 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 27 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Søren Foghsgaard, M.D. principal investigator
Soeren.Foghsgaard@regionh.dk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing cap II in people with Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 2 sites in Denmark.
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 2 inclusion and 2 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. 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?
Skin reactions according to Holgers (time frame: At time of sugical follow up visit (visit window of 7-14 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2017.