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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022107
Receipt No. R000025379
Scientific Title Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Date of disclosure of the study information 2016/04/27
Last modified on 2018/05/16

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Basic information
Public title Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Acronym Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Scientific Title Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Scientific Title:Acronym Panenteric surveillance of post allogeneic hematopoietic stem cell transplantat patients by using colon capsule endoscopy
Region
Japan

Condition
Condition post allogenic hematopoietic stem cell transplantation
Classification by specialty
Gastroenterology Hematology and clinical oncology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the sensitivity of colon capsule endoscopy as compared to the conventional endoscopy and enteroscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity of colon capsule endoscopy as compared to the conventional endoscopy and histopathology.
Key secondary outcomes Correlation between colon capsule endoscopic findings and Acute GVHD clinical grades.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Performing colon capsule endoscopy in the 21-28 day after post allogenic hematopoietic stem cell transplantation.
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 who are scheduled for allogenic hematopoietic stem cell transplantation.
Key exclusion criteria 1.Pregnancy
2.Having medical equipment in the body(e.g. pacemaker)
3.Intestinal obstruction.
4. Suspected or known Chrohn's disease.
5.Known to invasive gastrointestinal disease associate with Blood disease.
6. Contraindication for endoscopy
7. Patients who have morphine refractory diarrhea
8. Allergy of following medicine
8-1. Mosapride
8-2. Dimethicone
8-3. PEG with ascorvic acid
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hosoe
Organization Keio University Hospital
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35, Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-3353-1211
Email nhosoe@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe
Organization Keio University Hospital
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35, Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email nhosoe@z5.keio.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization Keio University Hospital
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 27 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 No longer recruiting
Date of protocol fixation
2016 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 27 Day
Last modified on
2018 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025379

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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