UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008650 |
|---|---|
| Receipt number | R000010163 |
| Scientific Title | Evaluation of efficacy of patency capsule for the assessment of endoscopic balloon dilatation in the small bowel stricture of Crohn's disease patients |
| Date of disclosure of the study information | 2012/08/09 |
| Last modified on | 2014/12/28 10:22:34 |
* 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
Evaluation of efficacy of patency capsule for the assessment of endoscopic balloon dilatation in the small bowel stricture of Crohn's disease patients
Acronym
Patency capsule for the assessment of endoscopic balloon dilatation in the small bowel stricture of Crohn's disease patients
Scientific Title
Evaluation of efficacy of patency capsule for the assessment of endoscopic balloon dilatation in the small bowel stricture of Crohn's disease patients
Scientific Title:Acronym
Patency capsule for the assessment of endoscopic balloon dilatation in the small bowel stricture of Crohn's disease patients
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of patency capsule for the assessment of stricture of Crohn's disease before and after the endoscopic balloon dilatation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Damage and retention rate of patency capsule after the balloon dilatation.
Key secondary outcomes
1. Evaluation of location of patency capsule retention before balloon dilatation.
2. Diameter, number of strictures and number of balloon dilation.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patency capsule
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
1) Patients with Crohn's disease with suspective of small bowel stricture by clinical symptoms or examinations such as CT.
2)Patients who agree to perform small bowel endoscopy or endoscopic balloon dilatation upon written informed consent.
Key exclusion criteria
1) Patients with ileus.
2) Allergic or intolerant to barium or lactose.
3)Pregnant or breast-feed women.
4) Patients who were considered not eligible to this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
takehar@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
stroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
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
| 2012 | Year | 08 | Month | 09 | 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
| 2012 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 08 | Day |
Last modified on
| 2014 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010163
