UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054381 |
|---|---|
| Receipt number | R000061171 |
| Scientific Title | Effectiveness and safety of a new clips designed for delivery using the duodenoscope for bleeding after endoscopic sphincterotomy. |
| Date of disclosure of the study information | 2024/05/13 |
| Last modified on | 2024/05/13 12:56:11 |
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Basic information
Public title
Effectiveness and safety of a new clips designed for delivery using the duodenoscope for bleeding after endoscopic sphincterotomy.
Acronym
Usefulness of SureClip for post-ES bleeding
Scientific Title
Effectiveness and safety of a new clips designed for delivery using the duodenoscope for bleeding after endoscopic sphincterotomy.
Scientific Title:Acronym
Usefulness of SureClip for post-ES bleeding
Region
| Japan |
Condition
Condition
Patients with endoscopic sphincterotomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively analyze the effectiveness and safety of SureClip (new clips designed for delivery using the duodenoscope) for hemostasis of post-ES bleeding.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of hemostasis
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients who underwent endoscopic sphincterotomy for biliary disease between January 2015 and December 2023 at the National Hospital Organization Kure Medical Center and Chugoku Cancer Center.
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kure Medical Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
737-0023
Address
Aoyamacho 3-1, Kure, Hiroshima Prefecture, Japan
TEL
+81823250142
yamaguchi.atsushi.uc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | ATSUSHI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Kure Medical Center and Chugoku Cancer Center
Division name
Department of Gastroenterology
Zip code
737
Address
Aoyamacho 3-1, Kure, Hiroshima Prefecture, Japan
TEL
+81823250142
Homepage URL
yamaguchi.atsushi.uc@mail.hosp.go.jp
Sponsor or person
Institute
Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address
Aoyamacho 3-1, Kure, Hiroshima Prefecture, Japan
Tel
+81823223111
yano.keigo.yf@mail.hosp.go.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
| 2024 | Year | 05 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.A.
Management information
Registered date
| 2024 | Year | 05 | Month | 13 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061171
