UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045837 |
|---|---|
| Receipt number | R000052329 |
| Scientific Title | Japanese Surgical Utilizing Medical Machine with Artificial Intelligence Trials |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2021/10/22 17:21:07 |
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Basic information
Public title
Toward laparoscopic cholecystectomy using an intraoperative artificial intelligence landmark guidance system: Exploratory study
Acronym
J-SUMMIT-C-01
Scientific Title
Japanese Surgical Utilizing Medical Machine with Artificial Intelligence Trials
Scientific Title:Acronym
J-SUMMIT-C-01
Region
| Japan |
Condition
Condition
benign gallbladder disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
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
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Accuracy of landmark detection
Key secondary outcomes
Operative time
Amount of blood loss
Conversion ratio to conventional surgery
Morbidity
Mortality
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
Have a gallbladder disease indicated for LC
Key exclusion criteria
1) Patients with severe cardiac dysfunction who are deemed unable to undergo general anesthesia based on an anesthesiologic or cardiovascular diagnosis.
Patients with severe respiratory disorders who are deemed unable to undergo general anesthesia based on an anesthesiologic or respiratory diagnosis.
3) Patients with severe liver dysfunction or severe cirrhosis
4) Patients who participated in another clinical trial in the last 4 months
5) Patients who are otherwise deemed ineligible for the study by the doctor in charge
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 | Hiroaki |
| Middle name | |
| Last name | Nakanuma |
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
http://www.surgery1.med.oita-u.ac.jp
h-nakanuma@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
h-nakanuma@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
大分大学医学部 消化器・小児外科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 22 | 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
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052329
