UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050776 |
|---|---|
| Receipt number | R000057012 |
| Scientific Title | Investigation of the presence of internal jugular vein valves using ultrasonography |
| Date of disclosure of the study information | 2023/04/06 |
| Last modified on | 2024/06/17 09:16:16 |
* 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
Investigation of the presence of internal jugular vein valves using ultrasonography
Acronym
Investigation of the presence of internal jugular vein valves using ultrasonography
Scientific Title
Investigation of the presence of internal jugular vein valves using ultrasonography
Scientific Title:Acronym
Investigation of the presence of internal jugular vein valves using ultrasonography
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the presence of internal jugular vein valves in healthy people using ultrasonography
Basic objectives2
Others
Basic objectives -Others
To investigate the presence of internal jugular vein valves in healthy people using ultrasonography
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence of internal jugular vein valves
Key secondary outcomes
cross-sectional area
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
| Other |
Interventions/Control_1
To investigate the presence of internal jugular vein valves using ultrasonography
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 20 <= Age <=60 years
2. Individual who provides written informed consent
3. Individual who is confirmed as healthy person by medical history, physical examination including electrocardiography and arterial pressure measurements
Key exclusion criteria
1. Individual who refuse to participate in the study
2. Individual who are judged as inappropriate participants by the principal investigator
3. Individual with cardiovascular diseases, autonomic imbalance, respiratory disease, severe systematic disease, medical history of those diseases
4. Individual with allergy for ultrasonic gel
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kato |
Organization
Nihon University School of Medicine
Division name
Department of Social Medicine, Division of Hygiene
Zip code
173-8610
Address
30-1 Oyaguchikamicho Itabashi-ku Tokyo
TEL
+81-3-3972-8111
kato.tomokazu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kato |
Organization
Nihon University School of Medicine
Division name
Department of Social Medicine, Division of Hygiene
Zip code
1738610
Address
30-1 Oyaguchikamicho Itabashi-ku Tokyo
TEL
+81-3-3972-8111
Homepage URL
kato.tomokazu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon Unniversity
Institute
Department
Personal name
TOMOKAZU KATO
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1 Oyaguchikamicho Itabashi-ku Tokyo
Tel
+81-3-3972-8111
med.kenjim@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 | 04 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057012
