Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
2 other identifiers
observational
270
5 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 16, 2025
CompletedStudy Start
First participant enrolled
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
July 8, 2026
July 1, 2026
1.9 years
April 1, 2025
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Intraoperative complications at surgery
During the Ponto-implantation surgery
Secondary Outcomes (9)
Assessment of procedure room variables
12 months after study start
To assess surgical parameters
During Ponto-implantation surgery
Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire
5-10 days after Ponto surgery
To assess postoperative events and complications
From day of surgery, through study completion, an average of 1 year
To assess rate of implant survival
3 months after surgery, and through study completion, an average of 1 year.
- +4 more secondary outcomes
Study Arms (2)
Retrospective group
Data gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards
Prospective group
Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires.
Interventions
Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.
Eligibility Criteria
Bone-conduction hearing device users
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (6)
Northern California Veterans Affairs Healthcare System
Sacramento, California, 95655, United States
Clinical Hospital from the Ribeirão Preto Medical School
São Paulo, São Paulo, 3900, Brazil
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Hospital Virgen de las Nieves
Granada, Andalusia, 18014, Spain
Sunderby Sjukhus
Luleå, Norrbotten County, 971 80, Sweden
Skåne University Hospital
Lund, Skåne County, 22185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr David Morris
Queen Elizabeth II Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2025
First Posted
April 16, 2025
Study Start
May 7, 2025
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
July 8, 2026
Record last verified: 2026-07