UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048983 |
|---|---|
| Receipt number | R000055805 |
| Scientific Title | Step-up hemostasis strategy for endoscopic sphincterotomy bleeding using a novel self-assembling peptide (STOP trial) |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/09/21 09:14:10 |
* 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
Step-up hemostasis strategy for endoscopic sphincterotomy bleeding using a novel self-assembling peptide (STOP trial)
Acronym
Step-up hemostasis strategy for endoscopic sphincterotomy bleeding using a novel self-assembling peptide (STOP trial)
Scientific Title
Step-up hemostasis strategy for endoscopic sphincterotomy bleeding using a novel self-assembling peptide (STOP trial)
Scientific Title:Acronym
Step-up hemostasis strategy for endoscopic sphincterotomy bleeding using a novel self-assembling peptide (STOP trial)
Region
| Japan |
Condition
Condition
Bleeding after EST
Classification by specialty
| Hepato-biliary-pancreatic medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of a novel self-assembling peptide hemostatic gel as a first-line endoscopic hemostasis technique for bleeding after EST.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The technical success rate for hemostasis
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
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Self-assembling peptide hemostatic gel as a first-line endoscopic hemostasis technique for bleeding after EST
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1. Bleeding after EST
2. Age from 20 years to 90 years old
3. Obtaining informed consent
Key exclusion criteria
1. Surgical altered anatomy
2. ASA 3 or over
3. ECOG PS 4
4. survival time under 3 months
5. inadequate inclusion, which is decided by attending doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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 at Osaka Medical and Pharmaceutical University
Address
2-7 Daigakuchou, Takatsukishi, Osaka
Tel
072-683-1221
rinri@ompu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-022
Org. issuing International ID_1
2022-022
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055805
