Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR) (NCT06930781)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (2 items).
Location: Northern California Veterans Affairs Healthcare System — Sacramento, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- No exclusion criteria have been set for this observational investigation
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Northern California Veterans Affairs Healthcare System — Sacramento, California
- Clinical Hospital from the Ribeirão Preto Medical School — São Paulo, São Paulo
- Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia
- Hospital Virgen de las Nieves — Granada, Andalusia
- Sunderby Sjukhus — Luleå, Norrbotten County
- Skåne University Hospital — Lund, Skåne County
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.