UMIN-CTR Clinical Trial

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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