BridgeMD
New treatment option for Hearing Loss, Conductive
Official title Pediatric Expansion Study of the Sentio System
ClinicalTrials.gov ID: NCT06976086
What this study is testing
- What it's testing
- This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 11
You may be able to join if
- Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
- Subject aged 3 to 11 years
- Subject with: 3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of...
- Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/ requirements, as determined by the...
- Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g...
You likely can't join if
- Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.
- Untreated ongoing middle ear infection at the time of surgery.
- Known or suspected contact allergy to silicone or other material used in the Sentio system.
- Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.
- Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
- Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
See the full eligibility criteria
- Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
- Subject aged 3 to 11 years
- Subject with: 3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL. 3.2 OR subject...
- Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/ requirements, as determined by the investigator.
- Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).
- For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.
- Sufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.
- Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.
- Untreated ongoing middle ear infection at the time of surgery.
- Known or suspected contact allergy to silicone or other material used in the Sentio system.
- Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.
- Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
- Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
- Any other known condition that the investigator determines could interfere with compliance or investigation assessments.
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
- Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
- For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.
- Known chronic or non-revisable vestibular or balance disorder.
- Known abnormally progressive hearing loss.
- Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or how well it works of the Sentio system as...
- Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.
- Known need for frequent MRI investigations for follow-up of other diseases.
- Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
- Nijmegen, Netherlands
- San Sebastián, Spain
- Seville, Spain
- Valencia, Spain
- Birmingham, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands; Nijmegen, Netherlands; San Sebastián, Spain; Seville, Spain; Valencia, Spain; Birmingham, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.