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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000047744
Receipt No. R000054394
Scientific Title ey of effects and challenges of 8K ultra-high-definition endoscopic surgery system
Date of disclosure of the study information 2022/05/12
Last modified on 2022/05/12

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Basic information
Public title A survey of effects and challenges of 8K ultra-high-definition endoscopic surgery system
Acronym ey of effects and challenges of 8K ultra-high-definition endoscopic surgery system
Scientific Title ey of effects and challenges of 8K ultra-high-definition endoscopic surgery system
Scientific Title:Acronym ey of effects and challenges of 8K ultra-high-definition endoscopic surgery system
Region
Japan

Condition
Condition Endoscopic surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Discover the effectiveness of the 8K endoscopic surgical system and examine its application in next-generation medical care and education.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes degree of satisfaction
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Surgeons, assistants and observers in thoracoscopic and laparoscopic procedures using 8K endoscopy
Key exclusion criteria Subjects who are deemed inappropriate by the principal investigator or principal investigator's staff due to the request of the subject or his/her family members will be excluded.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Inomata
Organization Oita University
Division name Department of Gastroenterological and Pediatric Surgery
Zip code 8795593
Address 1-1 Idaigaoka, Hasama-machi, Yufu-city, Oita
TEL 097-586-5843
Email k-yohei@oita-u.ac.jp

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Kono
Organization Oita University
Division name Department of Gastroenterological and Pediatric Surgery
Zip code 8795593
Address 1-1 Idaigaoka, Hasama-machi, Yufu-city, Oita
TEL 097-586-5843
Homepage URL
Email k-yohei@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

Funding Source
Organization Asian Medical Education and Training Support
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 Oita university ethics comittee
Address 1-1 Idaigaoka, Hasama-machi, Yufu-city, Oita
Tel 097-586-6380
Email rinrikenkyu@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
2022 Year 05 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 139
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 Completed
Date of protocol fixation
2020 Year 01 Month 01 Day
Date of IRB
2020 Year 04 Month 27 Day
Anticipated trial start date
2020 Year 04 Month 27 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We conducted a multicenter, cross-sectional, questionnaire survey. Data were collected from surgical participants who newly used and observed 8K UHD endoscopy in patients undergoing surgery

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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