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.
NCT Number: NCT06930781
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Clinical Hospital from the Ribeirão Preto Medical School, São Paulo, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During the Ponto-implantation surgery
Time frame: 12 months after study start
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: During Ponto-implantation surgery
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: 5-10 days after Ponto surgery
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: From day of surgery, through study completion, an average of 1 year
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: 3 months after surgery, and through study completion, an average of 1 year.
Implant survival will be assessed at least once, at 3 months. If follow-up data is available, implant survival will be assessed through study completion, an average of 1 year.
Time frame: Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
Time frame: 3 months after surgery, and through study completion, an average of 1 year.
Time frame: 3 months after surgery
Will be assessed using the standardised questionnaire International Outcome Inventory for Hearing Aids (IOI-HA) score at 3 months post-surgery. In the questionnaire, each item has five response choices proceeding from the worst outcome to the best outcome (1-5). The score will be presented as mean score with, standard deviation and median for the two groups.
Time frame: 3 months after surgery
Glasgow Benefit Inventory (GBI) benefit scores will be presented for total-, general-, social- and physical scores at 3 months post-surgery. The GBI uses a scale from -100 to +100, where scores above 0 indicate improved quality of life.
Contact information is provided by the study sponsor or research team.
Sara Al-Dalal
CONTACT
Sara Svensson
CONTACT
Oticon Medical
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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