UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036091 |
|---|---|
| Receipt number | R000041091 |
| Scientific Title | Open-label randomized controlled trials on the superiority of ultrasonic instruments in peripheral vascular access procedures in apheresis |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2022/04/01 18:29:35 |
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Basic information
Public title
Open-label randomized controlled trials on the superiority of ultrasonic instruments in peripheral vascular access procedures in apheresis
Acronym
Puncture by using ultrasonic instrument in apheresis
Scientific Title
Open-label randomized controlled trials on the superiority of ultrasonic instruments in peripheral vascular access procedures in apheresis
Scientific Title:Acronym
Puncture by using ultrasonic instrument in apheresis
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Rheumatoid arthritis
ANCA-associated vasculitis
Pemphisus
Pemphigoid
Ulcerative colitis
Crohn's disease
Arteriosclerosis obliterans
Myasthenia gravis
Multiple sclerosis
Optic nerve myelitis
Classification by specialty
| Medicine in general | Gastroenterology | Nephrology |
| Neurology | Clinical immunology | Dermatology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether the surgeons who are not proficient in apheresis puncture can show the higher blood vessel securing success rate by using ultrasonic instruments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Succeeded or failed in initial puncture
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Intervention group:
When the medical staffs puncture the blood vessels for apheresis, confirm the blood vessel variation in course using ultrasonic instruments.
Interventions/Control_2
Control group:
does not use ultrasonic instruments when the usual puncture in apheresis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.At the time of acquiring consent, the age is over 20 years old
2.One who gained document consent by the free will of the subject himself / herself with sufficient understanding after receiving sufficient explanation for participation in this research.
Key exclusion criteria
1.When agreement is acquired and the age is under 20
2.Those who have judged that the research director is inappropriate as the research subject.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Tamura |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
tnaoto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Makio |
| Middle name | |
| Last name | Kusaoi |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
makio.k@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
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
Ethical review board of Juntendo university, faculty of medicine
Address
3-1-3 Hongo, Bunkyo, Tokyo, Japan
Tel
03-3813-3111
hongo-rinri@juntendo.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
順天堂大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 11 | 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
0
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041091
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
