UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of vascular pattern of ulnar nerve in patients with cubital tunnel syndrome using contrast-enhanced ultrasonography
Acronym	Vascular pattern of ulnar nerve using contrast-enhanced ultrasonography
Scientific Title	Evaluation of vascular pattern of ulnar nerve in patients with cubital tunnel syndrome using contrast-enhanced ultrasonography
Scientific Title:Acronym	Vascular pattern of ulnar nerve using contrast-enhanced ultrasonography
Region	Japan

Condition
Condition	Cubital Tunnel Syndrome
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the vascular pattern of ulnar nerve in patients with cubital tunnel syndrome using contrast-enhanced ultrasonography by comparison with healthy controls.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify alteration of the vascular pattern of ulnar nerve in patients with cubital tunnel syndrome after the surgery
Key secondary outcomes	To compare the vascular pattern of ulnar nerve in patients with cubital tunnel syndrome with healthy controls

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Contrast-enhanced ultrasonography
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with cubital tunnel syndrome and healthy controls 2. Having received adequate explanation of the contents of the trial and given their written consent
Key exclusion criteria	1. Egg allergy 2. Severe heart disease 3. Severe lung disease 4. Determined to be ineligible by the physician in charge for any other reason
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norimasa Iwasaki
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL	011-706-5937
Email	niwasaki@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichiro Matsui
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL	011-706-5937
Homepage URL
Email	yuichirou@nyc.odn.ne.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 18 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	20
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	2014 Year 12 Month 01 Day
Date of IRB	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 12 Month 18 Day
Last follow-up date	2019 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	2014 Year 12 Month 15 Day
Last modified on	2019 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018300