UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059439 |
|---|---|
| Receipt number | R000066511 |
| Scientific Title | A Multicenter Prospective Study Using Video Review to Evaluate the Effectiveness of an AI-Based Surgical Navigation System in Preventing Intraoperative Organ Injury: The SAFER-AI Study |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/17 10:12:39 |
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Basic information
Public title
A Multicenter Prospective Study Using Video Review to Evaluate the Effectiveness of an AI-Based Surgical Navigation System in Preventing Intraoperative Organ Injury
Acronym
SAFER-AI Study
(Surgical Assistance For Enhanced Risk-avoidance using AI)
Scientific Title
A Multicenter Prospective Study Using Video Review to Evaluate the Effectiveness of an AI-Based Surgical Navigation System in Preventing Intraoperative Organ Injury: The SAFER-AI Study
Scientific Title:Acronym
SAFER-AI Study
(Surgical Assistance For Enhanced Risk-avoidance using AI)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to scientifically evaluate the effectiveness of the AI-based surgical navigation system "Eureka" in supporting intraoperative recognition of organ injury and preventing postoperative complications. This will be achieved by analyzing laparoscopic surgical videos in which organ injury previously occurred, and conducting a multi-reviewer assessment by experienced surgeons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of organ injury recognition in each video of organ injury cases in the normal video group (N group) and the Eureka video group (E group).
Key secondary outcomes
1 Concordance and time difference between the organ injury timing identified by video reviewers and the actual timecode of organ injury in each organ injury video from the N group and E group.
2 True negative rate (accuracy of correct no injury judgments) in non-injury videos from the N group and E group, as determined by reviewers.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Injury Cases (Video Materials):
1 Laparoscopic colorectal surgeries performed at either Kawaguchi Municipal Medical Center or Machida Municipal Hospital during the study period in which intraoperative organ injury was confirmed.
2 Patients aged 20 years or older.
3 Written informed consent obtained for research and educational use of surgical videos.
4 Videos deemed appropriate for study use following review by multiple board-certified expert colorectal surgeons.
Video Reviewers:
Practicing gastrointestinal surgeons who voluntarily agreed to participate without compensation.
Key exclusion criteria
Surgeons who performed or were involved in the original surgeries corresponding to the videos were excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shunjin |
| Middle name | |
| Last name | Ryu |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Digestive Surgery
Zip code
3330833
Address
180 NishiAraijuku, Kawaguchishi, Saitama, Japan
TEL
0482872525
systematic.ryu1121@gmail.com
Public contact
Name of contact person
| 1st name | Shunjin |
| Middle name | |
| Last name | Ryu |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Digestive Surgery
Zip code
3330833
Address
180 NishiAraijuku, Kawaguchishi, Saitama , Japan
TEL
0482872525
Homepage URL
systematic.ryu1121@gmail.com
Sponsor or person
Institute
Kawaguchi Municipal Medical Center
Institute
Department
Personal name
Shunjin Ryu
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Anaut Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Kawaguchi Municipal Medical Center
Address
180 NishiAraijuku, Kawaguchishi, Saitama, Japan
Tel
0482872525
systematic.ryu1121@gmail.com
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 | 10 | Month | 17 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066511
