Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOticon Medical
About this trial
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
Eligibility criteria
Qualifiers
Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
Signed informed consent (applicable for subjects answering questionnaires)
Disqualifiers
No exclusion criteria have been set for this observational investigation
Trial design
Treatments tested in this trial
- Ponto implantation
Treatment groups
270 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov