Ponto Procedures Performed Outside the Main Operating Room
This study is looking at the safety of Ponto implantation, a surgical procedure to implant a bone-anchored hearing device, when it's done outside of a main operating room. Ponto implantation helps improve hearing by sending sound directly to the inner ear through bone. The main goal is to see how often complications happen during the surgery. You may be able to join if you are an adult (18 or older) having a Ponto implantation outside of a main operating room from 2019 onwards. This is an observational study, meaning researchers will watch what happens in real-world care. The current recruitment status is unclear.
- Study design
- This is an observational, single-arm study that aims to include 270 participants. It combines looking back at past patient records and following new patients.
- What's involved
- If you agree to participate, you would complete three questionnaires after surgery and during follow-up, after your sound processor is active.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed after surgery and during follow-up, after the sound processor is loaded.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Dr David Morris · PRINCIPAL_INVESTIGATOR · Queen Elizabeth II Health Sciences Centre
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Intraoperative complications at surgeryDuring the Ponto-implantation surgery