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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | A Multicenter Prospective Study on the Efficacy of Small Intestinal Capsule Endoscopy in Hemodialysis Patients
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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 |
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Condition | ||||
Condition | Chronic kidney disease | |||
Classification by specialty |
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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.
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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 | |
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Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Organization | Keio university school of medicine | ||||||
Division name | Center for diagnostic therapeutic endoscopy | ||||||
Zip code | 160-8582 | ||||||
Address | Shinjuku-ku Shinanomachi 35 | ||||||
TEL | 0333531211 | ||||||
nhosoe@keio.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date analysis concluded |
Other | |
Other related information | The Japanese association for capsule endoscopy |
Management information | |||||||
Registered date |
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Last modified on |
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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 |