UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052013 |
|---|---|
| Receipt number | R000059302 |
| Scientific Title | A Prospective Observational Study to Evaluate the Ability of Artificial Intelligence Navigation System to Recognize Blood Vessels in Submucosal Dissection |
| Date of disclosure of the study information | 2023/08/26 |
| Last modified on | 2024/02/25 16:30:38 |
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Basic information
Public title
A Prospective Observational Study to Evaluate the Ability of Artificial Intelligence Navigation System to Recognize Blood Vessels in Submucosal Dissection
Acronym
A Prospective Observational Study to Evaluate the Ability of Artificial Intelligence Navigation System to Recognize Blood Vessels in Submucosal Dissection
Scientific Title
A Prospective Observational Study to Evaluate the Ability of Artificial Intelligence Navigation System to Recognize Blood Vessels in Submucosal Dissection
Scientific Title:Acronym
A Prospective Observational Study to Evaluate the Ability of Artificial Intelligence Navigation System to Recognize Blood Vessels in Submucosal Dissection
Region
| Japan |
Condition
Condition
Colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will use the AI navigation system created in a previous study (Construction of an Artificial Intelligence-based Risk Recognition System for Perforation Prevention in Colorectal Submucosal Dissection [Grant-in-Aid for Scientific Research: 20K16970]).
We will use this system for actual treatment videos to verify its ability to recognize blood vessels. unexpected bleeding during ESD requires hemostatic treatment with poor vision, which can take a long time and pose a risk of muscle layer damage and perforation. This is a pilot study to see if an AI-based navigation system can improve the safety of colorectal ESD treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vessel recognition rate (percentage of frames in which vessels were identified with an IoU index of 0.5 or higher)
Key secondary outcomes
1. average tumor diameter, average treatment time, en bloc resection rate, pathological depth, perforation rate, posterior hemorrhage rate
2. muscle layer recognition rate
3. submucosal layer recognition rate
4. hemorrhage point recognition rate
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
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
After obtaining consent, colorectal endoscopic submucosal dissection (colorectal ESD) is performed according to the usual clinical path (4 days/3 nights) currently in operation at Showa University Northern Hospital.
The scope and devices were PCF-H290TI (Olympus Co., Tokyo, Japan), disposable tip attachment (D-201-11304 [Olympus Co., Tokyo, Japan]), and Flush knife Ns 1.5mm (Fujinon Co., Saitama, Japan), exactly the same as those we usually use.
The treating physician must be an endoscopist with expertise in ESD (more than 50 cases of upper gastrointestinal ESD and more than 20 cases of colorectal ESD).
During ESD, the AI system is operated in real time, but the surgeon does not see the results but only records the output. Therefore, the ESD procedure itself is no different from the usual treatment, and the use of this system should have no impact.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older undergoing colorectal ESD who consented to this study
Key exclusion criteria
1. Contraindications to ESD (e.g., inability to take appropriate anticoagulation or antiplatelet withdrawal medications, poor general condition, etc.)
2. Patients with residual or recurrent disease after endoscopic treatment
3. Cases in which the lesion is expected to be deeper than T2 before treatment
4. Cases of high ESD difficulty such as anastomosis, diverticulum, appendiceal orifice, ileal valve, and anal canal
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Sakurai |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
045-949-7000
tatsuya08@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Sakurai |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
045-949-7000
Homepage URL
tatsuya08@med.showa-u.ac.jp
Sponsor or person
Institute
Digestive disease center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-u.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
| 2023 | Year | 08 | Month | 26 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059302
