UMIN-CTR Clinical Trial

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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email	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
Email	t.ishihara31@gmail.com

Sponsor
Institute	Kansai Rosai Hospital Cardiovascular Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014234

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