Clinical trial NCT06930781: Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Official title: Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss
Bone Anchored Hearing Aids
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bone-conduction hearing device users

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.

Detailed description: The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.

The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.

Eligibility 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

Primary outcomes:
measure: Intraoperative complications at surgery
timeFrame: During the Ponto-implantation surgery
Secondary outcomes:
measure: Assessment of procedure room variables
timeFrame: 12 months after study start
measure: To assess surgical parameters
timeFrame: During Ponto-implantation surgery
measure: Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire
timeFrame: 5-10 days after Ponto surgery
measure: To assess postoperative events and complications
timeFrame: From day of surgery, through study completion, an average of 1 year
measure: To assess rate of implant survival
timeFrame: 3 months after surgery, and through study completion, an average of 1 year.
measure: To assess time from surgery to sound processor loading
timeFrame: Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
measure: To assess sound processor usage time
timeFrame: 3 months after surgery, and through study completion, an average of 1 year.
measure: To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire
timeFrame: 3 months after surgery
measure: To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
state: Norrbotten
city: Lund
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
affiliation: Queen Elizabeth II Health Sciences Centre
name: Dr David Morris
role: PRINCIPAL_INVESTIGATOR
References: