UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of respiratory movement of inferior vena cava filters using four dimensional-computed tomography (prospective study)
Title of the study (Brief title)	Filter4D
Region	Japan

Condition
Condition	venous thromboembolism
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to evaluate the mechanism of filter fractures, caval penetration, and adjacent organ injuries by observing the respiratory movements of inferior vena cava filters on four dimensional computed tomography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	The measurements of vector's values of the top and leg's tips of the filters between the expiratory and inspiratory phases on four-dimensional computed tomography in patients with filters.
Key secondary outcomes	To assess the confidential levels of caval penetration and adjacent organ injuries by filters.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	four-dimensional computed tomography (approximately 1mSv during a few seconds)
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	The patients with inferior vena cava filters and the informed consent.
Key exclusion criteria	1. below the age of 20 years old 2. pregnant or possible pregnant women 3. not obtained the informed consent 4. determined as not applicable by the researchers
Target sample size	40

Research contact person
Name of lead principal investigator	Jun Koizumi
Organization	Tokai University School of Medicine
Division name	Diagnostic Radiology
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Email	jkoizumi@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Jun Koizumi
Organization	Tokai University School of Medicine
Division name	Diagnostic Radiology
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Homepage URL
Email	jkoizumi@is.icc.u-tokai.ac.jp

Sponsor
Institute	Diagnostic Radiology, Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Diagnostic Radiology, Tokai University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東海大学医学部付属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 03 Month 15 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 19 Day
Last modified on	2019 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040562