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 UMIN000011250
Receipt No. R000013186
Scientific Title Prospective controlled study comparing balloon-assisted entroscopy and MR enterography for small bowel lesion in patients with Crohn's disease.
Date of disclosure of the study information 2013/07/23
Last modified on 2018/07/30

* 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
Public title Prospective controlled study comparing balloon-assisted entroscopy and MR enterography for small bowel lesion in patients with Crohn's disease.
Acronym Progress Study
Scientific Title Prospective controlled study comparing balloon-assisted entroscopy and MR enterography for small bowel lesion in patients with Crohn's disease.
Scientific Title:Acronym Progress Study
Region
Japan

Condition
Condition Crohn's disease patient with small bowel involvement
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Detectability for small bowel lesion in patients with Crohn's disease by balloon-assisted enteroscopy comparison with MR enterography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Detection rate for small bowel lesion in patients with Crohn's disease by balloon-assisted enteroscopy comparison with MR enterography.
Key secondary outcomes 1) Detectability for transmural or extraluminal small bowel lesion in patients with Crohn's disease by MR enterography.
2) Detectability for small bowel stricture in patients with Crohn's disease by balloon-assisted enteroscopy and MR enterography.
3) Correlativity for enteroscopy score and MR enterography score.
4) Comparison with the findings of imaging modality (balloon-assisted enteroscopy, MR enterography) and disease activity index, CRP or fecal calprotectin.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 balloon-assisted enteroscopy
Interventions/Control_2 MR enterography
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Crohn's disease patient with small bowel involvement.
Key exclusion criteria 1) patients under 15 years of age.
2) patients with short bowel syndrome.
3) patients after (sub)total colectomy.
4) patients who have stoma.
5) claustrophobic patient.
6) patient with cardiac pacemaker.
7) patient with contraindications to MRI.
8) patients with allergy history for gadolinium contrast agent.
9) bronchial asthma patient.
10) patients with severe renal dysfunction.
11) patient with intestinal obstruction.
12) Patients who are not suitable for entry in this study by judged with physician.



Target sample size 110

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kenji Watanabe
Organization Osaka City University
Division name Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-3811
Email kenjiw@med.osaka-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kenji Watanabe
Organization Osaka City University
Division name Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-3811
Homepage URL
Email kenjiw@med.osaka-cu.ac.jp

Sponsor
Institute Research on Health and Labor Sciences Research Grants for Research on Intractable Diseases from the Ministry of Health, Labor and Welfare, Japan
Institute
Department

Funding Source
Organization Research Grants for Research on Intractable Diseases from the Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 東邦大学医療センター佐倉病院内科、自治医科大学消化器内科・放射線科、福岡大学筑紫病院消化器内科、慶應義塾大学医学部消化器内科、東京医科歯科大学消化器病態学

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 23 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
2013 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 23 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013186

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.