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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042018
Receipt No. 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

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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
Email 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
Email hideki_tarakawa@saimiya.com

Sponsor
Institute Department of Clinical Laboratory Medicine, Saiseikai Utsunomiya Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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