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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041904
Receipt No. R000047831
Scientific Title A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients
Date of disclosure of the study information 2020/10/01
Last modified on 2021/01/14

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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
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
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
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
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
Registered date File name

Research case data
Registered date File name


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