UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062702 |
|---|---|
| Receipt number | R000071794 |
| Scientific Title | Study for Developing Applications of Real-time Intraoperative Advanced Navigation |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/26 18:01:26 |
* 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
Study for Developing Applications of Real-time Intraoperative Advanced Navigation
Acronym
ARIA study
Scientific Title
Study for Developing Applications of Real-time Intraoperative Advanced Navigation
Scientific Title:Acronym
ARIA study
Region
| Japan |
Condition
Condition
Patients scheduled to undergo hepatobiliary and pancreatic surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a real-time navigation system for hepatobiliary and pancreatic surgery that processes and reconstructs preoperative and intraoperative imaging data, including ultrasonography, CT, and MRI, into two- and three-dimensional images and displays them in accordance with real-time surgical images. The positional accuracy, image-tracking accuracy, and usability of the developed system will also be evaluated to assess its potential clinical applicability.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the accuracy and usability of a surgical navigation system
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Undetermined (the study protocol does not explicitly distinguish primary from secondary outcomes; investigator confirmation is required).
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 20 years or older at the time informed consent is obtained.
2. Scheduled to undergo hepatobiliary and pancreatic surgery (open, laparoscopic, or robot-assisted).
Key exclusion criteria
No explicit exclusion criteria are specified in the study protocol.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Miyata |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
akmiyat@ncc.go.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Miyata |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
akmiyat@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511 (ext. 2597)
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-205
Org. issuing International ID_1
National Cancer Center Research Ethics Review Committee
Study ID_2
2024473NIe
Org. issuing International ID_2
The University of Tokyo Graduate School of Medicine and Faculty of Medicine Ethics Committee
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院（東京都）、東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
| 2022 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective observational study. Study cohort: 180 participants; validation cohort: 120 participants. No statistical analysis is planned in the study protocol.
Management information
Registered date
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071794
