UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053481 |
|---|---|
| Receipt number | R000061029 |
| Scientific Title | A Study to Evaluate the Preventive Effect of Purastat, a novel hemostatic peptide solution, to prevent bleeding after endoscopic submucosal dissection of a gastric tumor |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/01/30 18:27:14 |
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Basic information
Public title
A Study to Evaluate the Preventive Effect of Purastat, a novel hemostatic peptide solution, to prevent bleeding after endoscopic submucosal dissection of a gastric tumor
Acronym
A Study to Evaluate the Preventive Effect of Purastat, a novel hemostatic peptide solution, to prevent bleeding after endoscopic submucosal dissection of a gastric tumor
Scientific Title
A Study to Evaluate the Preventive Effect of Purastat, a novel hemostatic peptide solution, to prevent bleeding after endoscopic submucosal dissection of a gastric tumor
Scientific Title:Acronym
A Study to Evaluate the Preventive Effect of Purastat, a novel hemostatic peptide solution, to prevent bleeding after endoscopic submucosal dissection of a gastric tumor
Region
| Japan |
Condition
Condition
gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive potential of PuraStat, a hemostatic formulation, against bleeding in post-ESD gastric ulcers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-ESD bleeding
Key secondary outcomes
The duration from ESD to the onset of post-ESD bleeding and adverse events associated with PuraStat administration.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
PuraStat (1 mL) was used to stop bleeding during ESD, and after ESD, bleeding from the remaining blood vessels in the post-ESD ulcer was stopped by initiating coagulation using hemostatic forceps. Subsequently, the remaining 2 mL of PuraStat was applied to the post-ESD ulcer. Two experienced endoscopists (over 300 ESD cases) applied the medication to the post-ESD ulcers.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From May 2022 to March 2023, patients who underwent ESD for gastric diseases at our hospital
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kuniyo |
| Middle name | |
| Last name | Gomi |
Organization
Showa University Fujigaoka Hospital
Division name
Department of Gastroenterology
Zip code
2278501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Japan
TEL
0459711151
kunxaqua@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyo |
| Middle name | |
| Last name | Gomi |
Organization
Showa University Fujigaoka Hospital
Division name
Department of Gastroenterology
Zip code
2278501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Japan
TEL
0459711151
Homepage URL
kunxaqua@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
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
Showa University Clinical Research Support Center
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
ctsc.admin@ofc.showa-u.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
| 2024 | Year | 01 | Month | 30 | 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
101
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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061029
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
