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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036091
Receipt No. 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 2019/03/05

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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
Middle name
Last name Naoto Tamura
Organization Juntendo University School of Medicine
Division name Department of Internal Medicine and Rheumatology
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3813-3111
Email tnaoto@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makio Kusaoi
Organization Juntendo University School of Medicine
Division name Department of Internal Medicine and Rheumatology
Zip code
Address 2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email makio.k@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
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
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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