Actively Recruiting
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Led by Oticon Medical · Updated on 2025-05-18
270
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- No exclusion criteria have been set for this observational investigation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sunderby Sjukhus
Luleå, Norrbotten County, Sweden, 971 80
Actively Recruiting
2
Skåne University Hospital
Lund, Skåne County, Sweden, 22185
Actively Recruiting
Research Team
S
Sara Al-Dalal
CONTACT
S
Sara Svensson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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