UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042018 |
|---|---|
| Receipt number | R000047870 |
| Scientific Title | Assessment of lower extremity deep venous thrombosis using a pocket-sized ultrasound device |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2020/10/06 07:31:59 |
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Basic information
Public title
Assessment of lower extremity deep venous thrombosis using a pocket-sized ultrasound device
Acronym
Assessment of lower extremity deep venous thrombosis using a pocket-sized ultrasound device
Scientific Title
Assessment of lower extremity deep venous thrombosis using a pocket-sized ultrasound device
Scientific Title:Acronym
Assessment of lower extremity deep venous thrombosis using a pocket-sized ultrasound device
Region
| Japan |
Condition
Condition
deep venous thrombosis
Classification by specialty
| Medicine in general | Cardiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the performance of a pocket-sized ultrasound device for evaluating lower extremity deep venous thrombosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the diagnostic performance of two point method using a pocket-sized ultrasound device with high-end ultrasound devices as a reference standard for the assessment of proximal deep venous thrombosis of the lower extremity.
Key secondary outcomes
1) The concordance of the results between a pocket-sized device and high-end ultrasound devices.
2) The influence of body mass index and the swelling of the lower extremity on the diagnostic accuracy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
This study is scheduled to be performed during 24 months in 493 patients. Sonographers who have at least one and half years of experience with ultrasound of the lower extremity venous system participate in this study. First, one of the sonographers examines both sides of common femoral veins then popliteal veins using a pocket-sized ultrasound device with B mode (Vscan extended, GE Health Care). If a thrombus is visualized or if the vein is incompressible, the result is defined to be positive. If a thrombus is not visualized and if the femoral and popliteal veins are totally compressible, then the result is defined to be negative. Immediately after completion of the examination using the pocket-sized ultrasound device, another sonographer blinded to the previous results perform a formal systematic examination of lower extremity deep venous system using high-end ultrasound devices with B mode and Doppler mode.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients referred to the ultrasound laboratory for the assessment of deep venous thrombosis and who meet one of the followings:
1) swelling of either or both of the lower extremities
2) splinting or casting for the lower extremity
3) preoperative assessment due to treatment of malignant tumors
4) postoperative assessment of the lower extremity
5) suspected or confirmed pulmonary embolism
Key exclusion criteria
1) past medical history of deep venous thrombosis
2) the prior confirmation with other imaging modalities
3) the duplicated examination during the study period
Target sample size
493
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Izumi |
Organization
Saiseikai Utsunomiya Hospital
Division name
Department of Clinical Laboratory Medicine
Zip code
321-0974
Address
911-1 Takebayashi, Utsunomiya, Tochigi, Japan
TEL
028-626-5500
manabu_izumi@saimiya.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Tarakawa |
Organization
Saiseikai Utsunomiya Hospital
Division name
Department of Clinical Laboratory
Zip code
321-0974
Address
911-1 Takebayashi, Utsunomiya, Tochigi, Japan
TEL
028-626-5500
Homepage URL
hideki_tarakawa@saimiya.com
Sponsor or person
Institute
Department of Clinical Laboratory Medicine, Saiseikai Utsunomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Saiseikai Utsunomiya Hospital
Address
911-1 Takebayashi, Utsunomiya, Tochigi, Japan
Tel
028-626-5500
rieko_kawauchi@saimiya.com
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
| 2020 | Year | 10 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047870
