UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035821
Receipt No. R000040810
Official scientific title of the study Relationship between anemia and small bowel lesion in dialysis patients
Date of disclosure of the study information 2019/02/12
Last modified on 2019/02/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Relationship between anemia and small bowel lesion in dialysis patients
Title of the study (Brief title) Relationship between anemia and small bowel lesion in dialysis patients
Region
Japan

Condition
Condition small intestinal lesion
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the cause of unexplained anemia in dialysis patients
Basic objectives2 Others
Basic objectives -Others Scrutiny of small bowel lesions in dialysis patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between anemia and small bowel lesion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 small intestinal capsule endoscopy
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who have oral and written informed consent.
2) Patients who are planning to introduce or introduce hemodialysis therapy.
3) Gender and age are irrelevant.
Key exclusion criteria 1) Patients with swallowing disorder.
2) Patients with a very poor general condition.
3) Patients who can not confirm patency of the gastrointestinal tract.
4) A patient who is implanting a cardiac pacemaker or other medical electronic device in the body.
5) A patient who can not obtain consent for removal by endoscopic or surgical operation when the capsule endoscope stays.
6) Patients participating in other studies or clinical trials that directly or indirectly affect the results of this study.
7) Patient judged unsuitable as a subject by research researcher or research sharing doctor.
Target sample size 50

Research contact person
Name of lead principal investigator Kazuhide Higuchi
Organization Osaka Medical College
Division name Second department of internal medicine
Address 2-7, Daigaku-machi, Takatsuki
TEL 072-683-1221
Email higuchi@osaka-med.ac.jp

Public contact
Name of contact person Kazuhiro Ota
Organization Osaka medical college
Division name Second department of internal medicine
Address 2-7, Daigaku-machi, Takatsuki
TEL 072-683-1221
Homepage URL
Email clash_kaz@yathoo.co.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 12 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040810

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.