UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061755 |
|---|---|
| Receipt number | R000070671 |
| Scientific Title | A prospective clinical study of AI-assisted endoscopic diagnosis in chronic nasopharyngitis |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/31 20:54:41 |
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Basic information
Public title
Prospective observational study of AI-assisted endoscopic diagnosis in chronic nasopharyngitis
Acronym
NASO-AI Study
Scientific Title
A prospective clinical study of AI-assisted endoscopic diagnosis in chronic nasopharyngitis
Scientific Title:Acronym
NASO-AI Clinical Study
Region
| Japan |
Condition
Condition
Chronic nasopharyngitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively validate the performance of an AI-assisted endoscopic diagnostic model developed in a retrospective study and to evaluate its clinical utility in standardizing diagnosis and assessing treatment response in chronic nasopharyngitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between AI-derived scores and expert evaluations (weighted kappa coefficient and intraclass correlation coefficient)
Key secondary outcomes
Changes in AI scores before and after treatment, correlation with symptom visual analog scale scores, prediction of symptom improvement, diagnostic performance assessed by ROC-AUC and PR-AUC, calibration assessed by Brier score, and clinical utility evaluated by decision curve analysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients diagnosed with chronic nasopharyngitis who are scheduled to undergo epipharyngeal abrasive therapy and provide written informed consent
Key exclusion criteria
Patients with inadequate image quality, those who do not provide written informed consent, and those deemed ineligible by the principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate ENT Clinic
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
mogitateentjp@m08.itscom.net
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate Medical Corporation
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
Homepage URL
mogitateentjp@m08.itscom.net
Sponsor or person
Institute
Mogitate ENT Clinic
Institute
Department
Personal name
Manabu Mogitate
Funding Source
Organization
Mogitate ENT Clinic
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
Institutional Review Board: Rinko General Hospital Ethics Committee
Address
3-13-1 Nakajima, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
Tel
0442339336
None
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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study using endoscopic images and clinical data obtained during routine clinical practice without any additional intervention for research purposes.
Management information
Registered date
| 2026 | Year | 05 | Month | 31 | Day |
Last modified on
| 2026 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070671
