Status:
COMPLETED
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
Lead Sponsor:
Oticon Medical
Conditions:
Bone Conduction Deafness
Unilateral Deafness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 M...
Eligibility Criteria
Inclusion
- 18 years or older.
- Patient indicated for an ear level bone anchored sound processor.
- Healthy bone quality to allow for 4mm implant insertion.
Exclusion
- 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.
- 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)
Key Trial Info
Start Date :
September 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03807713
Start Date
September 7 2018
End Date
March 29 2022
Last Update
April 20 2022
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands, 6525