UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059767 |
|---|---|
| Receipt number | R000068141 |
| Scientific Title | A single-center pilot study of assistant-cooperative augmented reality (AR) surgical guidance in otolaryngologic surgery |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 16:39:42 |
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Basic information
Public title
A single-center pilot study to evaluate an assistant-cooperative augmented reality (AR) surgical guidance method in ear, nose and throat (ENT) surgery
Acronym
CoARS-Pilot
Scientific Title
A single-center pilot study of assistant-cooperative augmented reality (AR) surgical guidance in otolaryngologic surgery
Scientific Title:Acronym
CoARS-Pilot
Region
| Japan |
Condition
Condition
Cholesteatoma otitis media, chronic otitis media, severe sensorineural hearing loss, facial nerve palsy, Meniere's disease, chronic sinusitis, external auditory canal carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the feasibility and usefulness of a three-dimensional (3D) information presentation system in which a surgical assistant operates a head-mounted display to provide augmented-reality (AR)-based support to the operating surgeon during otologic and rhinologic procedures. Specifically, we will build an environment that enables intuitive intraoperative manipulation and referencing of patient-specific 3D models generated from computed tomography (CT). Through evaluation in both off-the-job training and actual surgical use, we will clarify its practical utility in the clinical setting as well as its educational impact.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation will be based on a postoperative questionnaire, with cognitive workload measured using the NASA Task Load Index (NASA-TLX). As a secondary endpoint, operative time will be assessed.
Statistical analysis:
* Subjective measures (NASA-TLX) will be compared between groups using a mixed-effects model.
* Operative time will be analyzed with a model that includes fixed effects for the intervention (AR guidance present vs absent), surgeon, and procedure. Results will be reported as time ratios (geometric mean ratios) with 95% confidence intervals.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Among consented patients who are randomized to the AR-supported arm, the following support will be provided. In the operating room, a display mirroring the head-mounted display (HMD) field of view will be placed next to the microscope/exoscope/endoscope monitor so that the operating surgeon can view it. During surgery, the assistant will wear the HMD and, using its pass-through function, manipulate the patient-specific 3D model while observing the operative field. The operating surgeon will not wear an HMD and will instead view the assistant-operated feed on the display. To maintain sterility, the assistant will perform manipulations outside the sterile field as needed.
AR support will include 3D reconstruction of the operative field, changes to the viewing angle of anatomical structures, distance measurements, and reconstruction/planning simulations. Use of conventional two-dimensional CT images will remain available and will not be restricted in the AR-supported arm.
Interventions/Control_2
Among consented patients randomized to the conventional-care arm, surgery will be performed according to standard practice on the basis of information from CT images (and other routine imaging, as applicable) viewed with the institutionally adopted image viewer. No AR support will be used.
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 who require surgical treatment for cholesteatoma, chronic otitis media, facial nerve palsy, severe hearing loss, Meniere's disease, external auditory canal carcinoma, or chronic rhinosinusitis and who provide informed consent.
Key exclusion criteria
Individuals who cannot personally provide informed consent.
Individuals with impaired capacity to make an independent decision about participation, or minors (<20 years of age).
Any other individuals deemed unsuitable for participation by the principal investigator or co-investigators.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Ito |
Organization
Institute of Science Tokyo
Division name
Department of Otorhinolaryngology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035009
taku.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimaru |
| Middle name | |
| Last name | Mizoguchi |
Organization
Institute of Science Tokyo
Division name
Department of Otorhinolaryngology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035009
Homepage URL
yosmizoguchi@gmail.com
Sponsor or person
Institute
Institute Of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute Of Science Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute Of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035009
rinri.adm@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
| 2025 | Year | 11 | 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
| 2025 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 12 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068141
