UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003349
Receipt number R000004030
Scientific Title Small Intestinal Surveillance of Chronic Hemodialysis Patients using Video Capsule Endoscopy
Date of disclosure of the study information 2010/03/17
Last modified on 2011/09/09 21:54:40

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Basic information

Public title

Small Intestinal Surveillance of Chronic Hemodialysis Patients using Video Capsule Endoscopy

Acronym

SCHEMA study

Scientific Title

Small Intestinal Surveillance of Chronic Hemodialysis Patients using Video Capsule Endoscopy

Scientific Title:Acronym

SCHEMA study

Region

Japan


Condition

Condition

Small intestinal abmormalities in chronic hemodialysis patients

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate small intestinal abmormalities in chronic hemodialysis patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Prevalence rate of the small intestinal disease in patients with chronic hemodialysys.

Key secondary outcomes

1) Correlation between capsule endoscopic findings and laboratory data.
2) Correlation between capsule endoscopic findings and administration dose of EPO and Fe.
3) One-year follow up study after capsule endoscopy.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Chronic hemodialysis Patients

Key exclusion criteria

1) Ppatients with dysphagia.
2) Patients who have history of the ileus or stricture or fistula of the intestine.
3) Diagnosed Crohn's disease
4) Patient with pacemaker or other medical electronic equipment.
5) Patient who have history of CAPD or CAPD patients.
6) Patients who have history of multiple abdominal operation or radiation therapy.
7) Patients who can not give informed consent for operation to retrieve the capsule.
8) The patients who have severe heart failure and respiratory failure.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.

Organization

Keio University

Division name

Division of Gastroenterology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.

Organization

Keio University

Division name

Division of Gastroenterology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Homepage URL


Email



Sponsor or person

Institute

Keio University,Division of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology, Keio University.
Capsule provider is Given Imaging Ltd.

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


Address


Tel


Email



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

多摩永山腎内科クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 03 Month 17 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

Completed

Date of protocol fixation

2010 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date

2011 Year 06 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information

To investigate small intestinal abmormalities in chronic hemodialysis patients using video capsule endoscopy


Management information

Registered date

2010 Year 03 Month 17 Day

Last modified on

2011 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name