UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045591 |
|---|---|
| Receipt number | R000051473 |
| Scientific Title | 3D model assisted otologic guided surgery |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/04/01 12:52:28 |
* 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
3D model assisted otologic guided surgery
Acronym
otologic guided surgery
Scientific Title
3D model assisted otologic guided surgery
Scientific Title:Acronym
otologic guided surgery
Region
| Japan |
Condition
Condition
Cholesteatoma, cochlear implant, temporal bone tumor
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of 3D model for reduction of the operation time and complications
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical time, complications
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The duration of the intervention is about 20 minutes at the time of surgery, and the number of interventions is only one. The intervention does not extend the surgical time or complications because it does not change the normal surgical procedure.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo surgery at our otolaryngology department for the purpose of treating cholesteatoma, temporal bone tumor and cochlear implants during the period from the approval of the examination to March 31, 2024.
Key exclusion criteria
Patients not to consent to participate in the research
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Medical and Dental University
Division name
Otorhinolaringology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo, Tokyo
TEL
03-5803-5308
taku.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Medical and Dental University
Division name
Otorhinolaringology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo, Tokyo
TEL
03-5803-5308
Homepage URL
taku.oto@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo
Tel
0358035308
taku.oto@tmd.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
| 2021 | Year | 11 | Month | 01 | 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
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051473
