Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT04039802
Eligibility Criteria:
Inclusion criteria test group:
* Age 4-9 years
* Indication for percutaneous bone-anchored hearing implant surgery with a BI300 implant
* Insertion using the linear incision technique
Inclusion criteria control group:
* Children who underwent implantation of a wide diameter implant using two- stage surgery between 2012 and 2018 at the Radboudumc
* Age 4-9 at the time of surgery
* Linear incision technique was used during surgery
Exclusion Criteria test group:
* Inability to show up at all follow-up visits
* Patients undergoing re-implantation
* Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
* Insufficient bone thickness ≤1mm, since conversion to two-stage surgery will be advocated
Exclusion Criteria control group
* Follow-up duration less than 1 year.
* Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus (at moment of implantation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT04039802
Study Brief:
Protocol Section:
NCT04039802