Bone Conduction DeafnessNCT03807713
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
A study testing Minimally Invasive Ponto Surgery in people with Bone Conduction Deafness and Unilateral Deafness, run by Oticon Medical at 1 site in Netherlands.
Trial summary
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness
- What is being tested?
- Minimally Invasive Ponto Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2018to 29 Mar 2022
- 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
- 18 years or older.
- Patient indicated for an ear level bone anchored sound processor.
- Healthy bone quality to allow for 4mm implant insertion.
Who cannot join
- Intraoperative switch to an alternative surgical technique
- Patients undergoing re-implantation (on the side being included in the study)
- Previous participation in the C47 study.
- Inability to participate in follow-up.
- Psychiatric disease in the medical history.
- Mental disability.
Show all 9Show fewer
- Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
- Patients with natural skin height of >12mm (as there will be additional skin reduction needed)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
- Being tested
- Minimally Invasive Ponto Surgery
- Medical subject headings
- Hearing Loss, Unilateral, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Ponto SurgeryDevice
Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Ponto Surgery | Other | Surgical method for installation of a bone anchored hearing system for hearing rehabilitation Receives: Device: Minimally Invasive Ponto Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbness (sensibility) around the implant
Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.
Measured: 6 months post surgery
Secondary outcomes (14)
Length of surgery
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
Measured: At surgery
Unplanned visits
Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).
Measured: 36 months
Adverse skin reactions
Investigate and compare the rate of adverse skin reactions using the Holgers Scale.
Measured: 36 months
Adverse skin reactions
Investigate and compare the rate of adverse skin reactions using the IPS scale.
Measured: 36 months
Pain perception by patient
Investigate and compare pain using a visual analogue scale 0-10
Measured: 36 months
Implant survivability
Investigate and compare implant survivability in terms of reported implant loss.
Measured: 36 months
Implant stability as measured with resonance frequency analysis, RFA.
Investigate and compare implant stability.
Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ).
Measured: 36 months
Surgical wound healing time
Investigate and compare healing time after surgery.
Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing.
Measured: 36 months
Wound dehiscence
Investigate wound dehiscence size after surgery.
Measured: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by SSQ questionnaire.
Measured: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by YORK questionnaire.
Measured: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by APHAB questionnaire.
Measured: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by GBI questionnaire.
Measured: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by GHSI questionnaire.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start7 Sep 2018
- Primary completion6 Nov 2019
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Conduction DeafnessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myrthe Hol, MD, PhD, Principal investigator, Radboud UMC, Department of Otorhinolaryngology. The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807713
- Sponsor's protocol ID
- C69
- Status last verified
- Mar 2021
- First submitted
- 8 Jan 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
- ClinicalTrials.gov ID
- NCT03807713
- Acronym / sponsor ID
- C69
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 17 Jan 2019 (actual)
- 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.
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Ponto Surgery | Other | Device: Minimally Invasive Ponto SurgerySurgical method for installation of a bone anchored hearing system for hearing rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older.
- Patient indicated for an ear level bone anchored sound processor.
- Healthy bone quality to allow for 4mm implant insertion.
Key exclusion criteria (9 listed)
- Intraoperative switch to an alternative surgical technique
- Patients undergoing re-implantation (on the side being included in the study)
- Previous participation in the C47 study.
- Inability to participate in follow-up.
- Psychiatric disease in the medical history.
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 |
|---|---|---|
| Minimally Invasive Ponto SurgeryMinimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems. | Device | Minimally Invasive Ponto Surgery |
Primary outcome
Numbness (sensibility) around the implant
Time frame: 6 months post surgery
Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.
14 secondary outcomes
Length of surgery
Time frame: At surgery
Unplanned visits
Time frame: 36 months
Adverse skin reactions
Time frame: 36 months
Adverse skin reactions
Time frame: 36 months
Pain perception by patient
Time frame: 36 months
Implant survivability
Time frame: 36 months
Implant stability as measured with resonance frequency analysis, RFA.
Time frame: 36 months
Surgical wound healing time
Time frame: 36 months
Wound dehiscence
Time frame: 36 months
Quality of Life Assessment
Time frame: 36 months
Quality of Life Assessment
Time frame: 36 months
Quality of Life Assessment
Time frame: 36 months
Quality of Life Assessment
Time frame: 36 months
Quality of Life Assessment
Time frame: 36 months
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 20 Apr 2022.
- Individual participant dataSharing planned: No
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.
Myrthe Hol, MD, PhD principal investigator
Radboud UMC, Department of Otorhinolaryngology. The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Ponto Surgery in people with Bone Conduction Deafness and Unilateral Deafness, run by Oticon Medical at 1 site in Netherlands.
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 3 inclusion and 9 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 20 Apr 2022. 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 Netherlands. 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?
Numbness (sensibility) around the implant (time frame: 6 months post 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 20 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.