UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052843 |
|---|---|
| Receipt number | R000054355 |
| Scientific Title | Validation of a Recently Developed Fluoroscopic Video Analysis Workstation (Radwis) for Reliable Diagnosis of Acute Pulmonary Thromboembolism |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2023/11/19 20:01:09 |
* 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
An Exploratory Study on the Diagnosis of Pulmonary Thromboembolism (PTE) Using Radwisp and Determination of Treatment Efficacy
Acronym
Validation of a Recently Developed Fluoroscopic Video Analysis Workstation (Radwis) for Reliable Diagnosis of Acute Pulmonary Thromboembolism
Scientific Title
Validation of a Recently Developed Fluoroscopic Video Analysis Workstation (Radwis) for Reliable Diagnosis of Acute Pulmonary Thromboembolism
Scientific Title:Acronym
Validation of a Recently Developed Fluoroscopic Video Analysis Workstation (Radwis) for Reliable Diagnosis of Acute Pulmonary Thromboembolism
Region
| Japan |
Condition
Condition
acute pulmonary thromboembolism
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate Radwisp as a diagnostic tool for APE and evaluate its potential for patients who present with symptoms of suspected APE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of Radwisp-based Diagnosis of APE or Absence of APE
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 24 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
10 residents and 10 cardiologists in our hospital.
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Fukamachi |
Organization
Nihon University School of Medicine
Division name
Caridiology
Zip code
173-8610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL
0339728111
fukamachi.daisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Fukamachi |
Organization
Nihon University School of Medicine
Division name
Caridiology
Zip code
173-8610
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL
0339728111
Homepage URL
fukamachi.daisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon university itabashi hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
tokyo
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon university itabashi hospital
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
Tel
0339728111
komoda.nozomi@nihon-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
| 2023 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054355
