UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042020 |
|---|---|
| Receipt number | R000047946 |
| Scientific Title | Multicenter survey of impossible swallowing of capsule endoscopy and use of capsule delivery system including AdvanCE system in Japan |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2021/10/05 12:52:03 |
* 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
Multicenter survey of impossible swallowing of capsule endoscopy and use of capsule delivery system including AdvanCE system in Japan
Acronym
AdvanCE-J study
Scientific Title
Multicenter survey of impossible swallowing of capsule endoscopy and use of capsule delivery system including AdvanCE system in Japan
Scientific Title:Acronym
AdvanCE-J study
Region
| Japan |
Condition
Condition
Small bowel and large bowel diseases
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the usefulness and safety of capsule delivery system in adults and children in a nationwide multicenter retrospective survey.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Adverse events of capsule delivery system
Key secondary outcomes
Endoscopic delivery time
Success rate of capsule delivery to the duodenum
Adverse events of capsules
Total enteroscopy or colonoscopy rate
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
Examinees who underwent small bowel capsule endoscopy, colon capsule endoscopy, and patency capsule
Key exclusion criteria
Examinees who were judged as inaapropriate to enroll in this study by attending doctors
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Gastroenterology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Ikue |
| Middle name | |
| Last name | Tanigawa |
Organization
Fujita Health University School of Medicine
Division name
IRB
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2860
Homepage URL
https://the-jace.org/clinical_research/
research@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for Capsule Endoscopy
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
Fujita Health University School of Medicine, IRB
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2860
research@fujita-hu.ac.jp
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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
774
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
| 2020 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 08 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2020 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047946
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
