Bone Conduction DeafnessNCT03281967
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
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
- 9 Jun 2017to 21 Dec 2020
- 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 Implant in patients indicated and counselled for Bone Anchored Hearing System.
| 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 surgery area
The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments.
Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.
Measured: 6 months post surgery
Secondary outcomes (9)
Time needed for surgery
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
Measured: At surgery
Unplanned visit
Investigate and compare the number of unplanned visits, unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).
Measured: 36 months
Adverse Events
Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.
Measured: 36 months
Pain perception by patient
Investigate and compare patient perceived pain.
For pain measurement, the patient is asked if pain around the implant is present. If it's present, duration is assessed (more or less than 6 weeks present). In addition, increase of pain is assessed during manipulation of the abutment (tightening of or tapping on the abutment). The patient is asked to score the perceived pain on a scale of 0-10; with 0 being no pain at all and 10 being the highest pain the patient had ever experienced.
Measured: 36 months
Implant survivability
Investigate and compare implant survivability.
Implant survivability is monitored by following upon patients and recording implant losses if and when they occur. The investigators do not expect multiple patients to have an implant loss. However, this may happen due to different reasons. The investigators would track the circumstances under which the implant loss occurred and the time between implant installation and loss.
Measured: 36 months
Implant stability as measures by Implant stability quotient.
Investigate implant stability.
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 using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.
Measured: 36 months
Quality of Life Assessment
Investigate and compare subjective benefit as measured by APHAB, GBI and GHSI questionnaires.
Measured: 36 months
Aesthetic Assessment
Investigate and compare scar assessment by surgeon and patient (POSAS).
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 posted13 Sep 2017
- Study start9 Jun 2017
- Primary completion13 Jun 2018
- Study completion21 Dec 2020
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
- NCT03281967
- Sponsor's protocol ID
- C63
- Status last verified
- Mar 2021
- First submitted
- 31 Aug 2017
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
- ClinicalTrials.gov ID
- NCT03281967
- Acronym / sponsor ID
- C63
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 13 Sep 2017 (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 Implant in patients indicated and counselled for Bone Anchored Hearing System. | Device | Minimally Invasive Ponto Surgery |
Primary outcome
Numbness (sensibility) around surgery area
Time frame: 6 months post surgery
The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments. Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.
9 secondary outcomes
Time needed for surgery
Time frame: At surgery
Unplanned visit
Time frame: 36 months
Adverse Events
Time frame: 36 months
Pain perception by patient
Time frame: 36 months
Implant survivability
Time frame: 36 months
Implant stability as measures by Implant stability quotient.
Time frame: 36 months
Surgical wound healing time
Time frame: 36 months
Quality of Life Assessment
Time frame: 36 months
Aesthetic 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 3 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Bone Conduction Deafness
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
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
Active, not recruiting
Pediatric Expansion Study of the Sentio System
Hearing Loss, Conductive, Hearing Loss, Mixed
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruiting
Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction
Mixed Hearing Loss, Conductive Hearing Loss
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 3 Mar 2021. 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 surgery area (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 3 Mar 2021.