Tokyo, April 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061155) titled 'A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System' on April 3.
Study Type:
Observational
Primary Sponsor:
Institute - St. Marianna University School of Medicine
Condition:
Condition - Conductive hearing loss and mixed hearing loss
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively evaluate changes in audiological outcomes and patient-reported outcomes (quality of life) in patients undergoing bone conduction implant surgery using the Cochlea Osia system, and to determine its clinical effectiveness.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
=65 years elderly group
Key exclusion criteria - Participants meeting any of the following criteria will be excluded:
Hearing loss primarily due to inner ear pathology
Severe cognitive impairment that precludes completion of questionnaires
Presence of active middle ear infection or cholesteatoma
Cranial anatomy or skin condition unsuitable for Osia system implantation
Bone thickness less than 3 mm
Any other condition deemed inappropriate for study participation by the investigator
Target Size - 48
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 03 Day
Anticipated trial start date - 2026 Year 04 Month 30 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069879
Disclaimer: Curated by HT Syndication.
