UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045743
Receipt No. 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 2021/10/13

* 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 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
Email 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
Email shin709@juntendo.ac.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

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
Email 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 Preinitiation
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
2023 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
2021 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052220

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.