UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051915 |
|---|---|
| Receipt number | R000059233 |
| Scientific Title | Study on intraoperative ABR monitoring and postoperative ABR measurement of active middle ear implant VSB surgery using the AcoustiAP system |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2024/02/14 12:12:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on intraoperative ABR monitoring and postoperative ABR measurement of active middle ear implant VSB surgery using the AcoustiAP system
Acronym
ABR measurement of active middle ear implant VSB using the AcoustiAP system
Scientific Title
Study on intraoperative ABR monitoring and postoperative ABR measurement of active middle ear implant VSB surgery using the AcoustiAP system
Scientific Title:Acronym
ABR measurement of active middle ear implant VSB using the AcoustiAP system
Region
| Japan |
Condition
Condition
conductive and mixed hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the AcoustiAP system for intraoperative and postoperative ABR measurements in VSB surgery to enhance accuracy in the surgery and postoperative hearing outcomes: Investigation and validation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between intraoperative ABR Thresholds and VSB Stimulation Thresholds after 2 months surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Enhancing Accurate Coupling of FMT for Reliable Inner Ear Transmission of Sound Information in VSB Surgery: Utilizing the AcoustiAP System for Intraoperative and Postoperative ABR Measurements. Investigating the Correlation Between ABR Thresholds and VSB Stimulation Thresholds and Validating Its Effectiveness.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients Scheduled for or Undergoing Artificial Middle Ear VSB Surgery
2 Patients who can provide Written Consent for Research Participation Voluntarily
3 Cases with an Age of 5 Years or Older at the Time of Consent Acquisition
Key exclusion criteria
1 Cases with Inner Ear malformation
2 Cases with systemic complications
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare, Mita hospital
Division name
Otorhinolaryngology
Zip code
108-8329
Address
1-4-3, Mita, MInato-ku, Tokyo
TEL
03-3451-8121
masa12_1@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takahashi |
Organization
International University of Health and Welfare, Mita hospital
Division name
Otorhinolaryngology
Zip code
108-8329
Address
1-4-3, Mita, MInato-ku, Tokyo
TEL
03-3451-8121
Homepage URL
masa12_1@iuhw.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-4-3, Mita Minato-ku, Tokyo
Tel
03-3451-8121
masa12_1@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059233
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
