UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050701 |
|---|---|
| Receipt number | R000057755 |
| Scientific Title | A Multicenter Randomized Controlled Trial Comparing With and Without Artificial Intelligence-based Intraoperative Image Navigation System Use in Laparoscopic Surgery |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/03/28 15:15:54 |
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Basic information
Public title
Research to evaluate the usefulness of artificial intelligence-based surgical navigation systems
Acronym
ImNavi trial
Scientific Title
A Multicenter Randomized Controlled Trial Comparing With and Without Artificial Intelligence-based Intraoperative Image Navigation System Use in Laparoscopic Surgery
Scientific Title:Acronym
ImNavi trial
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the benefit of intraoperative use of an artificial intelligence-based surgical anatomy navigation system in laparoscopic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
the time required for each target organ to be recognized by surgeons after its initial appearance on the monitor.
Key secondary outcomes
intraoperative target organ injuries, intraoperative complications, operation time, blood loss, length of postoperative hospital stay, postoperative complications within 30 days, postoperative male sexual dysfunction at 1 month after surgery, surgeon's confidence in recognition of each target organ, and postoperative fatigue of the primary surgeon according to the Piper Fatigue Scale-12.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform the surgery as usual, and verbally declare that the target organ for recognition has appeared on the screen at the time it is recognized.
Interventions/Control_2
Perform the surgery using an AI-based navigation system, and the surgeon verbally declares this when he/she recognizes that the target organ for recognition has appeared on the screen.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients between 18 and 80 years of age, who are scheduled to undergo laparoscopic left-sided colorectal resection will be included in the ImNavi trial. As long-term outcomes are not included in the endpoints, patients with any colorectal diseases will be eligible.
Key exclusion criteria
Patients with emergent surgery, with expected intra-abdominal severe adhesion, with a significant anatomical anomaly, and deemed unsuitable by the doctor in charge will be excluded.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Ito |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Medical Device Innovation
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471331111
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Kitaguchi |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Medical Device Innovation
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471331111
Homepage URL
dkitaguc@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Masaaki Ito
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional research ethics review board of the National Cancer Center Hospital
Address
6-5-1, Kashiwanoha
Tel
0471331111
irst@ncc.go.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 | 03 | Month | 31 | 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
| 2023 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057755
