UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045731 |
|---|---|
| Receipt number | R000052206 |
| Scientific Title | Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence |
| Date of disclosure of the study information | 2021/10/12 |
| Last modified on | 2021/10/12 16:23:25 |
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Basic information
Public title
Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Acronym
Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Scientific Title
Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Scientific Title:Acronym
Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Region
| Japan |
Condition
Condition
Benign gallbladder disease
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop artificial intelligence (AI) based intraoperative landmark teaching system for laparoscopic cholecystectomy and confirm the function of the AI device.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of landmark detection
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Benign gallbladder disease for which laparoscopic cholecystectomy is indicated
Key exclusion criteria
1) Patients with severe cardiac dysfunction who were diagnosed by anesthesiology and cardiology and were judged to be unable to undergo general anesthesia.
2) Patients with severe respiratory distress who were judged to be unable to undergo general anesthesia based on the diagnosis of anesthesiology and respiratory medicine.
3) Patients with severe liver damage or severe cirrhosis
4) Patients who participated in other clinical trials within 4 months
5) Other patients who the doctor in charge of this study deems inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Inomata |
Organization
Oita University Faculty of Medicine
Division name
Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
TEL
097-586-5843
oitagps@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuro |
| Middle name | |
| Last name | Fujinaga |
Organization
Oita University Faculty of Medicine
Division name
Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
TEL
097-586-5843
Homepage URL
a-yoshimura@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
Tel
097-586-5843
a-yoshimura@oita-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
| 2021 | Year | 10 | Month | 12 | 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
| 2020 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052206
