UMIN-CTR Clinical Trial

Basic information
Public title	Single-center prospective observational study on the usefulness of Top 100 features of capsule endoscopy
Acronym	Prospective study of Top 100
Scientific Title	Single-center prospective observational study on the usefulness of Top 100 features of capsule endoscopy
Scientific Title:Acronym	Top 100 study
Region	Japan

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

Objectives
Narrative objectives1	To analysis the detection rates of lesions with top 100 features based on the conventional capsule endoscopy reading.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Comparison of detected numbers of lesions among conventional, quick-view, and top 100 reading of small bowel and colon capsule endoscopy
Key secondary outcomes	1. Comparison of time to diagnose with conventional, quick-view, and top 100 reading 2. Comparison of the numbers of overlooked lesions among conventional, quick-view, and top 100 reading 3. Comparison of capsule findings and conventional colonoscopy and double-balloon enteroscopy

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	10 years-old <=
Age-upper limit	95 years-old >
Gender	Male and Female
Key inclusion criteria	Consenting patients
Key exclusion criteria	Inappropirate patients such as small and large bowel stenotic diseases
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Ohmiya
Organization	Fujita Health University
Division name	Department of Gastroenterology
Zip code	4701192
Address	1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL	0562939240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Ikue Middle name Last name Tanigawa
Organization	Fujita Health University
Division name	IRB
Zip code	4701192
Address	1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL	0562932860
Homepage URL
Email	research@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University Department of Gastroenterology
Institute
Department

Funding Source
Organization	Fujita Health 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	IRB
Address	1-98 Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
Tel	0562932860
Email	f-irb@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 02 Month 25 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	Ongoing
Results date posted	2019 Year 09 Month 30 Day
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	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 07 Month 26 Day
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 04 Month 30 Day
Date trial data considered complete	2022 Year 05 Month 10 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	detection rate of lesions, time to diagnosis, overlook rate

Management information
Registered date	2019 Year 09 Month 30 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043501