Evaluating outcomes of Ponto procedures done outside the main operating room
Official title: Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Run by Oticon Medical · NCT06930781 · Data updated 2026-11-12
This study looks at how well Ponto implant surgeries done outside the main operating room work for patients and whether they have any complications.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Oticon Medical Industry-sponsored |
| Locations | 6 sites (Sacramento, California and 5 other locations) |
| Status | Recruiting |
| Started | May 7, 2025 |
| Main results expected | March 30, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06930781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing Ponto implantation in an out-of-OR setting.
✕Probably not a fit
Patients who are not undergoing Ponto implantation or those under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the clinical outcomes of Ponto-implantations performed in out-of-OR settings. It combines both retrospective and prospective approaches, reviewing patient charts from 2019 onwards and enrolling new patients scheduled for out-of-OR procedures. The study aims to assess the complication rates associated with these procedures while collecting patient-reported outcomes through questionnaires after surgery and during follow-up.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and effectiveness of performing Ponto procedures outside traditional operating rooms, potentially improving access for patients.
How similar studies have gone: While there may be limited data on out-of-OR Ponto procedures, similar studies in other surgical fields have shown promising outcomes, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * No exclusion criteria have been set for this observational investigation
Where it's running
-
Northern California Veterans Affairs Healthcare System
Sacramento, California, United States Recruiting -
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada Recruiting -
Clinical Hospital from the Ribeirão Preto Medical School
São Paulo, São Paulo, Brazil Active not recruiting -
Hospital Virgen de las Nieves
Granada, Andalusia, Spain Active not recruiting -
Sunderby Sjukhus
Luleå, Norrbotten County, Sweden Active not recruiting -
Skåne University Hospital
Lund, Skåne County, Sweden Active not recruiting
Study contacts
- Principal investigator: Dr David Morris — Queen Elizabeth II Health Sciences Centre
- Study coordinator: Sara Al-Dalal
- Email: srld@oticonmedical.com
- Phone: +46 70-149 25 03
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.