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Clinical Survey of Oticon Medical Healing Cap

Primary Purpose

Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Healing cap II

About this trial

This is an interventional supportive care trial for Conductive Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet
Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of Healing cap II

Arm Description

Single arm study using a new healing cap as intervention

Outcomes

Primary Outcome Measures

Skin reactions according to Holgers

Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.

Secondary Outcome Measures

Fitting of sound processor at surgical follow-up visit

Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.

Full Information

NCT ID

NCT02274129

First Posted

October 14, 2014

Last Updated

November 23, 2017

Sponsor

Oticon Medical

1. Study Identification

Unique Protocol Identification Number

NCT02274129

Brief Title

Clinical Survey of Oticon Medical Healing Cap

Official Title

C51 - Clinical Survey of Oticon Medical Healing Cap

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

April 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oticon Medical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Use of Healing cap II

Arm Type

Experimental

Arm Description

Single arm study using a new healing cap as intervention

Intervention Type

Device

Intervention Name(s)

Healing cap II

Intervention Description

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

Primary Outcome Measure Information:

Title

Skin reactions according to Holgers

Description

Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.

Time Frame

At time of sugical follow up visit (visit window of 7-14 days after surgery)

Secondary Outcome Measure Information:

Title

Fitting of sound processor at surgical follow-up visit

Description

Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.

Time Frame

At time of surgical follow up visit (visit window of 7-14 days after surgery)

Other Pre-specified Outcome Measures:

Title

Surgical time

Description

Time taken to perform the surgery

Time Frame

Recorded at surgery visit

Title

Surgical complications

Description

Any complications during and after surgery

Time Frame

At the surgical visit

Title

Surgical complications

Description

Any complications during and after surgery

Time Frame

At time of surgical follow up visit (visit window of 7-14 days after surgery)

Title

Implant stability

Time Frame

Duration of study (12 months of enrollment)

Title

Use of Healing cap II

Description

Ease of use of Healing cap II and effect on surgical dressing

Time Frame

At the surgical visit

Title

Use of Healing cap II

Description

Ease of use of Healing cap II and effect on surgical dressing

Time Frame

At time of surgical follow up visit (visit window of 7-14 days after surgery)

Title

Skin healing at first follow-up visit

Time Frame

At time of surgical follow up visit (visit window of 7-14 days after surgery)

Title

Pain and numbness

Time Frame

Duration of study (12 months of enrollment)

Title

Time of fitting and type of sound processor

Time Frame

Duration of study (12 months of enrollment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Søren Foghsgaard, M.D.

Organizational Affiliation

Soeren.Foghsgaard@regionh.dk

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Gentofte

State/Province

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

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

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Survey of Oticon Medical Healing Cap

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