UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of a bioinstrumentation using shape deformation of amputated uupper limb
Acronym	Bioinstrumentation of amputated upper limb
Scientific Title	Clinical research of a bioinstrumentation using shape deformation of amputated uupper limb
Scientific Title:Acronym	Bioinstrumentation of amputated upper limb
Region	Japan

Condition
Condition	Amputated upper limb
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of our bioinstrumentation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safty, operability and efficacy
Key secondary outcomes

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	Treatment
Type of intervention	Other
Interventions/Control_1	usage of bioinstrumentation
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	after one year of amputation
Key exclusion criteria	Diabates, peripheral nerve disorder, Complication, pregnancy, malignancy and other infelicity
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Hara
Organization	Faculty of Medicine, University of Tsukuba
Division name	Orthopaedics
Zip code	3058577
Address	1-1-1. Tennodai, Tsukuba, Ibaraki, Japan
TEL	0298533914
Email	yukihara@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Hara
Organization	University of Tsukuba
Division name	Orthopaedics
Zip code	3058577
Address	Tennodai, Tsukuba, Japan
TEL	0298533914
Homepage URL
Email	yukihara@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Koshiyama technology promotion foundation JKA machine industry promotion assistance business Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of tsukuba hospital
Address	1-1-1tennnoudai tsukuba ibaraki
Tel	0298533219
Email	tcredo@md.tsukuba.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	2013 Year 08 Month 01 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	Open public recruiting
Date of protocol fixation	2013 Year 07 Month 10 Day
Date of IRB	2013 Year 07 Month 10 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2030 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	2013 Year 07 Month 30 Day
Last modified on	2021 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013264