UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037102 |
|---|---|
| Receipt number | R000042270 |
| Scientific Title | Prototype single-balloon enteroscopy with passive-bending and high force transmission insertion tube improves depth of insertion in the small intestine. |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2019/06/18 20:59:20 |
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Basic information
Public title
Prototype single-balloon enteroscopy with passive-bending and high force transmission insertion tube improves depth of insertion in the small intestine.
Acronym
Prototype single-balloon enteroscopy and insertability in stricturing CD
Scientific Title
Prototype single-balloon enteroscopy with passive-bending and high force transmission insertion tube improves depth of insertion in the small intestine.
Scientific Title:Acronym
Prototype single-balloon enteroscopy and insertability in stricturing CD
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of EBD using single-balloon enteroscopy for small intestinal strictures of CD. We also clarify the factors contributing to surgery and the effectiveness of the passive bending mechanism in EBD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative surgery free rate
Key secondary outcomes
Factors that contribute to surgery
The insertability of a prototype single balloon enteroscope (SBE)
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
CD patients who underwent EBD for small intestinal stricture lesions from October 2005 to December 2018 at Shiga University of medical science.
Key exclusion criteria
Patients without EBD for small bowel lesions (eg, cases with EBD only for gastric lesions and large intestine lesions).
Patients who could not track after EBD.
Patient using double balloon small intestine enteroscopy for EBD.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Andoh |
Organization
Shiga university of medical science
Division name
Gastroenterology
Zip code
520-2192
Address
Tukinowa Seta Otu-shi Shiga-ken Jpan
TEL
077-548-2111
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga university of medical science
Division name
Clinical nutrition
Zip code
520-2192
Address
Tukinowa Seta Otu-shi Shiga-ken Jpan
TEL
077-548-2111
Homepage URL
hqmed2@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of medical science
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shiga university of medical science
Address
Tukinowa Seta Otu-shi Shiga-ken Jpan
Tel
077-548-3576
hqrec@belle.shiga-med.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective study. This study is a verification study to clarify the effectiveness of EBD. The type of study is a past cohort study.
Management information
Registered date
| 2019 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042270
