UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter survey of impossible swallowing of capsule endoscopy and use of capsule delivery system including AdvanCE system in Japan
Acronym	AdvanCE-J study
Scientific Title	Multicenter survey of impossible swallowing of capsule endoscopy and use of capsule delivery system including AdvanCE system in Japan
Scientific Title:Acronym	AdvanCE-J study
Region	Japan

Condition
Condition	Small bowel and large bowel diseases
Classification by specialty	Gastroenterology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the usefulness and safety of capsule delivery system in adults and children in a nationwide multicenter retrospective survey.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Adverse events of capsule delivery system
Key secondary outcomes	Endoscopic delivery time Success rate of capsule delivery to the duodenum Adverse events of capsules Total enteroscopy or colonoscopy rate

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	Examinees who underwent small bowel capsule endoscopy, colon capsule endoscopy, and patency capsule
Key exclusion criteria	Examinees who were judged as inaapropriate to enroll in this study by attending doctors
Target sample size	6000

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Ohmiya
Organization	Fujita Health University School of Medicine
Division name	Department of Gastroenterology
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562-93-9240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Ikue Middle name Last name Tanigawa
Organization	Fujita Health University School of Medicine
Division name	IRB
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562-93-2860
Homepage URL	https://the-jace.org/clinical_research/
Email	research@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine Department of Gastroenterology
Institute
Department

Funding Source
Organization	The Japanese Association for Capsule Endoscopy
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Fujita Health University School of Medicine, IRB
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel	0562-93-2860
Email	research@fujita-hu.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	藤田医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 06 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	Open public recruiting
Date of protocol fixation	2020 Year 09 Month 04 Day
Date of IRB	2020 Year 09 Month 11 Day
Anticipated trial start date	2020 Year 09 Month 30 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 05 Month 09 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	Nothing

Management information
Registered date	2020 Year 10 Month 05 Day
Last modified on	2020 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047946

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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