UMIN-CTR Clinical Trial

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
Email	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
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	Ethical review board of Juntendo university, faculty of medicine
Address	3-1-3 Hongo, Bunkyo, Tokyo, Japan
Tel	03-3813-3111
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041091