UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045743 |
|---|---|
| Receipt number | R000052220 |
| Scientific Title | micro-orbital vibration measurements and vibration analyses by the AI in ESS |
| Date of disclosure of the study information | 2021/10/13 |
| Last modified on | 2024/06/05 12:29:07 |
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Basic information
Public title
orbital vibration measurements and vibration analyses by AI in endoscopic sinus surgery (ESS).
Acronym
orbital vibration measurements and analyses in ESS
Scientific Title
micro-orbital vibration measurements and vibration analyses by the AI in ESS
Scientific Title:Acronym
micro-orbital vibration measurements and analyses in ESS
Region
| Japan |
Condition
Condition
paranasal benign disease with ESS
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
orbital measurements by micro-vibration during ESS
Basic objectives2
Others
Basic objectives -Others
analyses of measured data by AI and the prediction of orbital complications
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measurements of orbital micro-vibration during ESS
Key secondary outcomes
analyses of the measured vibration data by AI
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
measurements of orbital micro-vibration during ESS
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
paranasal sinus benign disease with ethmoidectomy in ESS under general anesthesia
Key exclusion criteria
sinonasal malignant disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Ito |
Organization
Juntendo University Urayasu Hospital
Division name
Otorhinolaryngology
Zip code
279-0021
Address
2-1-1, Tomioka,Urayasu, Chiba
TEL
047-353-3111
shin709@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Ito |
Organization
Juntendo University Urayasu Hospital
Division name
Otorhinolaryngology
Zip code
279-0021
Address
2-1-1, Tomioka,Urayasu, Chiba
TEL
047-353-3111
Homepage URL
shin709@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports,
science and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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 | 10 | Month | 13 | 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 | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052220
