臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 28, 2019
Last modified on	April. 01, 2022
Trial ID	jRCTs032180098

Scientific Title	Repair of peripheral nerve gap by direct lengthening of both nerve stumps (Peripheral nerve elongation trial)
Public Title	Peripheral nerve elongation trial (Peripheral nerve elongation trial)

Completion date	Sept. 08, 2021
Result actual enrolment	1
Baseline Characteristics	Patients who injured peripheral nerve defedt of limbs, 20 years old more and less than 65 years old
Participant flow	end
Adverse events	none
Outcome measures	One patients had undergo this study. Prrimary outcome of this study was safety of the nerve lengthening methods. There were no adverse event.
Brief summary	One patients had undergo this study. Prrimary outcome of this study was safety of the nerve lengthening methods. There were no adverse event.
Date of posting of results summaries	April. 01, 2022
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	none
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032180098

Contact for Scientific Queries	Name	Yamazaki Masashi
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, Tsukuba, Ibaraki
	Telephone	+81-29-853-3219
	E-mail	masashiy@md.tsukuba.ac.jp
Contact for Public Queries	Name	Hara Yuki
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, Tsukuba, Ibaraki
	Telephone	+81-29-853-3219
	E-mail	yukihara@md.tsukuba.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 10, 2017
Actual date of first enrollment		July. 17, 2020
Target sample size		3
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who injured peripheral nerve defect of limbs 20 years old or more and less than 65 years old
	Exclusion Criteria	The diabetic patient who is under medication The patient who have peripheral nerve disorder The patient who has a serious heart disorder The patient who has a doubt or diagnostic neoplastic lesion within 5 years before agreement The woman that during the pregnancy or the pregnancy is doubted The patient who received other study drugs within current 1 month. The patient who has not ability for agreement with own will. The patient who has not ability for agreement by the reading and writeing The patient who has been judged to be inappropriate as a subject by the doctor incharge
	Age Minimum	20age old over
	Age Maximum	64age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Peripheral nerve disorder
Intervention(s)		Neurorapphy
Health Condition(s) Keyword		Peripheral nerve gap
Intervention(s) Keyword		Nerve elongation
Health Condition(s) Code		C26-240-30
Intervention(s) Code		E04-450-50
Primary Outcome(s)		Safety of the nerve lengthening method
Secondary Outcome(s)		Nerve regeneration( MMT, Semmes-Weinstein monofilament test,Tinel sign) Electromyography

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan society for the promotion of science
Secondary Sponsor	Not applicable

Name of Certified Review Board	Tsukuba University Clinical Research Review Board
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Ibaraki
Telephone	+81-29-853-3914
E-Mail	t-credo.adm@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	Dec. 28, 2018

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	April. 01, 2022	(this page)	Changes
4	Dec. 07, 2021	Detail	Changes
3	Feb. 16, 2021	Detail	Changes
2	Dec. 04, 2020	Detail	Changes
1	Jan. 28, 2019	Detail

List of change history