UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054299 |
|---|---|
| Receipt number | R000061935 |
| Scientific Title | Assessment of the educational effectiveness of a video-sharing system for remote endoscopists |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/05/01 16:33:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of the educational effectiveness of a video-sharing system for remote endoscopists
Acronym
Assessment of the educational effectiveness of a video-sharing system for remote endoscopists
Scientific Title
Assessment of the educational effectiveness of a video-sharing system for remote endoscopists
Scientific Title:Acronym
Assessment of the educational effectiveness of a video-sharing system for remote endoscopists
Region
| Japan |
Condition
Condition
Pancreato-biliary disease, infectious colitis,Inflammatory bowel disease including disease to be differentiated
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are disparities in endoscopic diagnostic techniques among medical institutions, particularly concerning refractory gastrointestinal disorders and tumorous conditions. Merely sharing diagnostic information brochures, static images, and conducting awareness and educational activities at conferences and research meetings have not been sufficient for standardizing diagnostic techniques across medical facilities. Therefore, we aim to investigate whether utilizing the real-time video-sharing system developed by Heart Organization Co., Ltd. to share endoscopic videos among multiple hospitals and provide diagnostic support in actual endoscopic procedures can be beneficial for enhancing endoscopic diagnostic capabilities in regional healthcare facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of lesion detection and imaging capability of Endoscopic Ultrasound (EUS) Examination for Pancreato-biliary disease, and evaluation of diagnostic ability of colonoscopy for inflammatory bowel disease or differential Diagnoses.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
For one month, a remote specialist will conduct education for four endoscopists using a video-sharing system to share real-time videos, engage in discussions via audio, and annotate the endoscopic screens.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Criteria for selecting practitioners:
1. Those who hold a medical license and have completed their initial training.
2. Those who do not hold certification as a specialist in gastrointestinal endoscopy from the Japan Gastroenterological Endoscopy Society or certification as a specialist from the Japan Gastroenterological Society.
3. Even if they hold the above qualifications, those who have received a request for guidance from their department head or chief physician regarding the relevant examination.
Criteria for selecting patients:
1. Patients aged 20 and above.
2. Patients undergoing endoscopic ultrasound (EUS) for biliary and pancreatic diseases or colonoscopy for suspected inflammatory bowel disease or similar conditions at Yokoshi Municipal General Hospital.
3. Cases where endoscopic videos have been shared via Caseline for cases performed by the chief of the department, between the implementation permission date and March 31, 2029, for medical support.
4. Patients who have consented to participate in this study and have provided written consent.
Key exclusion criteria
Exclusion criteria:
Criteria for practitioners:
In case of not wishing to participate in the study
Criteria for patients:
1. Individuals deemed by a physician to be in poor overall health, making participation in this study difficult.
2. Individuals who have difficulty understanding the examinations sufficiently.
3. Patients who cannot provide consent to participate in this study.
4. Individuals deemed by a physician to have difficulty participating in this study for other reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mikihiro |
| Middle name | |
| Last name | Fujiya |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2462
fjym@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Moriichi |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2462
Homepage URL
morimori@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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
| 2024 | Year | 05 | Month | 07 | 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
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061935
