Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
NCT ID: NCT04279236
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
64 participants
OBSERVATIONAL
2020-06-15
2024-12-10
Brief Summary
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The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).
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Detailed Description
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The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS). The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single-arm
In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and an additional follow-up visit after surgery.
Abbreviated Profile Hearing Aid Benefit (APHAB)
An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on 2 occasions.
Glasgow Benefit Inventory (GBI)
An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on 2 occasions.
Additional follow-up visit
There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).
Interventions
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Abbreviated Profile Hearing Aid Benefit (APHAB)
An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on 2 occasions.
Glasgow Benefit Inventory (GBI)
An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on 2 occasions.
Additional follow-up visit
There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).
Eligibility Criteria
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Inclusion Criteria
* Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines.
* Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected.
* Skin thickness of 12mm or less at the implant site
Exclusion Criteria
* Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
* Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator.
* Any other known condition that the investigator determines could interfere with compliance or study assessments.
18 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Locations
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Silverstein Institute
Sarasota, Florida, United States
Otolaryngology Associates
Indianapolis, Indiana, United States
New York Eye and Ear Infirmary
New York, New York, United States
Northwest Ear Institute
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Hospital Universitario de Donostia
San Sebastián, Gipuzkoa, Spain
Countries
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Other Identifiers
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BC100
Identifier Type: -
Identifier Source: org_study_id
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