Evaluating outcomes of Ponto procedures done outside the main operating room
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
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 |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oticon Medical Industry-sponsored |
| Locations | 2 sites (Luleå, Norrbotten County and 1 other locations) |
| Trial ID | NCT06930781 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing Ponto implantation in an out-of-OR setting.
Not a fit: Patients who are not undergoing Ponto implantation or those under 18 years old may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Luleå, Norrbotten County and 1 other locations
- Sunderby Sjukhus — Luleå, Norrbotten County, Sweden (Recruiting)
- Skåne University Hospital — Lund, Skåne County, Sweden (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.