UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002564
Receipt No. R000003125
Scientific Title The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Date of disclosure of the study information 2009/09/30
Last modified on 2011/04/01

* 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 The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Acronym The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Scientific Title The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Scientific Title:Acronym The evaluation of new Agile patency capsule for patients with suspected stricture who undergo capsule endoscopy
Region
Japan

Condition
Condition The patients with established Crohn's disease and the other established or suspected small bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of new Agile patency capsule for patients with established Crohn's disease and the other small bowel disease who undergo capsule endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of retention of capsule endoscope in patients confirmed patency with new Agile patency capsule
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 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 Period: from 1st, September, 2009 to 31st, July, 2010
The number of examined patients: a total 50 cases/ 2 institutions (25 cases/ institution)
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with established Crohn's disease and the other established or suspected small bowel disease
Key exclusion criteria 1: Patients with established retention or impaction of capsule endoscopy by the other examinations for small bowel
2: No bowel movements for over 4 days
3: Abdominal operated patients with difficulty to confirm safety to perform this investigation with the other examinations for small bowel
4: Subjects with pacemakers or other implanted electromedical devices
5: Swallowing disorder
6: Pregnant women
7: Patients with difficulty to perform the prescribed examinations
8: A serious patient
9: Participating or planned patient to the other clinical trials
10: The patient who the physician judged as inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Watanabe, M.D., Ph.D.
Organization Graduate School of Medicine, Osaka City University
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3811
Email

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

Sponsor
Institute Graduate School of Medicine, Osaka City University, Department of Gastroenterology
Institute
Department

Funding Source
Organization None
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 大阪市立大学医学部付属病院(大阪府)、名古屋大学医学部付属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 30 Day
Last modified on
2011 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003125

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.