Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOticon Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
No exclusion criteria have been set for this observational investigation
Trial population
Bone-conduction hearing device users
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Ponto implantation
DevicePonto 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.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Retrospective group1 intervention
Group B: Prospective group1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative complications at surgery
Time frame
During the Ponto-implantation surgerySecondary outcomes
1
Assessment of procedure room variables
To make an assessment of how procedure rooms that are used for Ponto out-of-OR surgeries look like. Will be measured using the 'Procedure room used for Out-of-OR Ponto-surgery questionnaire'
Time frame
12 months after study start2
To assess surgical parameters
With this outcome, the aim is to assess the surgical variables present during Ponto out-of-OR surgeries. A series of yes or no questions will be presented in a form to the surgeon regarding the use of anesthesia, sedatives, implants, and abutments of different lengths. The results will be presented in a table.
Time frame
During Ponto-implantation surgery3
Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire
Score is reported on a scale of 5 steps, were the lowest value (1) is the worst and the highest value is the best (5)
Time frame
5-10 days after Ponto surgery4
To assess postoperative events and complications
All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication.
Time frame
From day of surgery, through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov