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Clinical Survey of Oticon Medical Healing Cap

NCT ID: NCT02274129

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-04-19

Brief Summary

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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

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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.

Conditions

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Conductive Hearing Loss Mixed Hearing Loss Unilateral Partial Deafness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Use of Healing cap II

Single arm study using a new healing cap as intervention

Group Type EXPERIMENTAL

Healing cap II

Intervention Type DEVICE

Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery

Interventions

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Healing cap II

Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients eligible for treatment with a bone anchored hearing aid
* 18 years or older

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Søren Foghsgaard, M.D.

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet

Gentofte Municipality, Hellerup, Denmark

Site Status

Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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C51

Identifier Type: -

Identifier Source: org_study_id