UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients
Acronym	PROCEED study
Scientific Title	A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients
Scientific Title:Acronym	PROCEED study
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the correlation between gastrointestinal lesions and unexplained gastrointestinal bleeding on hemodialysis (Obscure GI Bleeding) or anemia of unknown origin, and to evaluate the usefulness of small intestinal capsule endoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic yield of small intestinal capsule endoscopy for hemodialysis patients
Key secondary outcomes

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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients on maintenance dialysis who are clinically determined to undergo small bowel capsule endoscopy and have known or suspected small bowel disease due to unexplained gastrointestinal bleeding or unexplained anemia.
Key exclusion criteria	Contraindication for small bowel capsule endoscopy.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Haruhiko Middle name Last name Ogata
Organization	Keio university school of medicine
Division name	Center for diagnostic therapeutic endoscopy
Zip code	160-8582
Address	Shinjuku-ku Shinanomachi 35
TEL	0333531211
Email	nhosoe@keio.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Hosoe
Organization	Keio university school of medicine
Division name	Center for diagnostic therapeutic endoscopy
Zip code	160-8582
Address	Shinjuku-ku Shinanomachi 35
TEL	0333531211
Homepage URL
Email	nhosoe@keio.jp

Sponsor
Institute	Keio university school of medicine
Institute
Department

Funding Source
Organization	Covidien co Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Japanese association for capsule endoscopy
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics commiteKeio University
Address	Shinjuku-ku Shinanomachi 35
Tel	0333531211
Email	med-rinri-jimu@adst.keio.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	日本カプセル内視鏡学会会員施設

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 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
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Results Delayed
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 12 Month 13 Day
Date of IRB	2020 Year 01 Month 08 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The Japanese association for capsule endoscopy

Management information
Registered date	2020 Year 09 Month 27 Day
Last modified on	2021 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047831

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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