UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012176 |
|---|---|
| Receipt number | R000014234 |
| Scientific Title | Evaluation of the Efficacy and Safety of Short Time Bed Rest to Stop Bleeding with Exoseal Study |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2015/04/13 13:32:05 |
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Basic information
Public title
Evaluation of the Efficacy and Safety of Short Time Bed Rest to Stop Bleeding with Exoseal Study
Acronym
E-stone Study
Scientific Title
Evaluation of the Efficacy and Safety of Short Time Bed Rest to Stop Bleeding with Exoseal Study
Scientific Title:Acronym
E-stone Study
Region
| Japan |
Condition
Condition
Peripheral artery disease, Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of short time bed rest after using Exoseal
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score (efficacy outcome)
Major adverse event within 30 days (safety outcome)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bed rest time is 2.5 hours after using Exoseal.
Interventions/Control_2
Bed rest time is 4.0 hours after using Exoseal.
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
Patiens for whom Exoseal is used to get hemostasis.
Key exclusion criteria
Patients who did not agree with this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Ishihara |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
Address
Inabaso 3-1-69, Amagasaki, Hyogo, Japan
TEL
06-6416-1221
t.ishihara31@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Ishihara |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
Address
Inabaso 3-1-69, Amagasaki, Hyogo, Japan
TEL
06-6416-1221
Homepage URL
t.ishihara31@gmail.com
Sponsor or person
Institute
Kansai Rosai Hospital Cardiovascular 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
Address
Tel
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
| 2013 | Year | 10 | 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
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
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 30 | Day |
Last modified on
| 2015 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014234
