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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042008
Receipt No. R000047944
Scientific Title Assistant skill in ESD with a Clutch Cutter
Date of disclosure of the study information 2020/10/05
Last modified on 2021/05/26

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Basic information
Public title Assistant skill in gastric endoscopic submucosal dissection using a Clutch Cutter
Acronym Assistant skill in gastric endoscopic submucosal dissection using a Clutch Cutter
Scientific Title Assistant skill in ESD with a Clutch Cutter
Scientific Title:Acronym Assistant skill in ESD with a Clutch Cutter
Region
Japan

Condition
Condition Gastric tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine how assistant skill level affected the technical outcomes of gastric ESD-C using an ex vivo porcine training model.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total procedure time
Key secondary outcomes En bloc resection rate, complete procedure rate, perforation rate, and each procedure time/speed for mucosal incision or submucosal dissection.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All operators were gastrointestinal trainees with experience performing less than 20 ESD procedures. One assistant was defined as an expert who had experience in not only assisting but also operating in at least 50 ESD procedures. The remaining 2 assistants were defined as non-experts with experience in operating or assisting in no more than 10 ESD procedures.
Key exclusion criteria None
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Esaki
Organization Kyushu University
Division name Department of Medicine and Bioregulatory Science, Graduate School of Medicine
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 0926425286
Email esaki_saiseikai@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Esaki
Organization Kyushu University
Division name Department of Medicine and Bioregulatory Science, Graduate School of Medicine
Zip code 812-8582
Address 3- 1 - 1 Maidashi, Higashi-ku
TEL 0926425286
Homepage URL
Email esaki_saiseikai@yahoo.co.jp

Sponsor
Institute Kitakyushu Municipal Medical Center
Institute
Department

Funding Source
Organization Kyushu University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitakyushu Municipal Medical Center
Address 2-1-1 Bashaku Kokurakita-Ward Kitakyushu-City
Tel 093-541-1831
Email byou-iryou-chiken01@kitakyu-cho.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
2020 Year 10 Month 05 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 32
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 10 Month 05 Day
Date of IRB
2019 Year 01 Month 31 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2020 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information This was a retrospective observational study.

Management information
Registered date
2020 Year 10 Month 05 Day
Last modified on
2021 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047944

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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