Clinical trial NCT06634784: Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.
Official title: The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Conductive
Hearing Loss, Mixed
Children Under 5 Years
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 5 years old with BONEBRIDGE BCI 602 implants

Brief summary: This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant. This observational study, which is both retrospective (looking back) and prospective (looking forward), will take place at multiple hospitals. The main goal is to see if the BONEBRIDGE implant is safe for young children within 12 months after surgery.

Primary Goal: The study's main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety.

Secondary Goals:

Hearing Improvement: Using tests like the Göttinger Speech Intelligibility Test (Word Recognition Scores) to see how much the hearing improves with the implant.

Treatment History: Surgeons will fill out questionnaires about how the treatment went.

Quality of Life: Parents will answer questions about their child's quality of life using the GCBI questionnaire at least 12 months after the implant.

The study will last up to 12 months, including enrolling participants and performing all necessary procedures. The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data.

By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant, this study aims to determine if it is safe and effective for young children.


Eligibility criteria: Inclusion Criteria:

Children who received the BONEBRIDGE BCI 602 implant before the age of five and have had the implant for at least 12 months.

Ability to perform the German language test. Willingness and ability to undergo all tests required by the study. Signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data.

Exclusion Criteria:

Inability to perform audiological tests due to psychological, emotional, or related physical disorders.

Failure to meet any inclusion criteria. Any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.

Primary outcomes:
measure: Evaluation of speech intelligibility using the Göttinger Speech Intelligibility Test.
timeFrame: Day 1
Secondary outcomes:
measure: Assessment of quality of life using the GCBI questionnaire
timeFrame: Day 1
measure: Evaluation based on treatment history questionnaires for surgeons
timeFrame: Day 1
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Hals-, Nasen- und Ohrenheilkunde
state: Schleswig-Holstein
Study officials:
References: