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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000012176 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Peripheral artery disease, Coronary artery disease | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014234 |