UMIN-CTR Clinical Trial

Basic information
Public title	Studies to investigate the anatomy of the superficial human body using an in-house-made 3D-ultrasonography system, and its feasibility in clinical practice
Acronym	A study of the superficial anatomy using an in-house-made 3D-ultrasonography system
Scientific Title	Studies to investigate the anatomy of the superficial human body using an in-house-made 3D-ultrasonography system, and its feasibility in clinical practice
Scientific Title:Acronym	A study of the superficial anatomy using an in-house-made 3D-ultrasonography system
Region	Japan

Condition
Condition	1) healthy volunteers 2) superficial anomalous conditions, tumors and other related pathologies
Classification by specialty	Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the anatomy of the superficial human body using an in-house-made 3D-ultrasonography system, and to evaluate its feasibility in clinical practice
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic values of collected 3D-Images for each part of the superficial human body/ superficial anomalous conditions, tumors or other related pathologies Dynamic ultrasonographic data for motion analyses of the superficial human body
Key secondary outcomes	Differences of anatomical characteristics between each ages and individuals

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Healthy volunteers are scanned using an in-house-made 3D-ultrasonography system. Obtained ultrasound videos are installed into PCs to be stacked into 3D images. Using these 3D images, unknown anatomical and/or biomechanical findings are investigated. Furthermore their diagnostic values of the ultrasonographic 3D images are evaluated by comparing to other imaging modality using data obtained from pathological cases.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy volunteer/patients who have superficial anomalous conditions, tumors or other related pathologies Candidates from whom informed consent or assent can be obtained. For patients, who are younger than 7 years, informed consent from their parents can be obtained.
Key exclusion criteria	Subjects from whom informed consent or assent can't be obtained. For patients, who are younger than 7 years, informed consent from their parents can't be obtained.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Saito
Organization	Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name	Department of Plastic and Reconstructive Surgery
Zip code	606-8507
Address	54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3613
Email	susumus@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Susumu Middle name Last name Saito
Organization	Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name	Department of Plastic and Reconstructive Surgery
Zip code	606-8507
Address	54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3613
Homepage URL
Email	susumus@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	2014 Year 08 Month 18 Day

Related information
URL releasing protocol	https://doi.org/10.1097/PRS.0000000000003937
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1097/PRS.0000000000003937
Number of participants that the trial has enrolled	63
Results	A total of 63 cases were included, including 32 thumb polydactyly, 14 polydactyly of the foot, 1 syndactyly, 15 skin diseases such as keloids, and 1 secondary deformity of polydactyly. The anatomical location, distribution, and degree of development of the thenar muscle were evaluated for cases with thumb polydactyly. We found that the development of the thenar muscle was limited depending on the level of the skeletal bifurcation of the radial thumb.
Results date posted	2022 Year 08 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Congenital cases including thumb polydactyly
Participant flow	Registration of participants was done in the outpatient department and the examination was conducted on the same day.
Adverse events	There was no adverse effect.
Outcome measures	The anatomical location, distribution, and degree of development of the thenar muscle
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 19 Day
Date of IRB	2014 Year 07 Month 23 Day
Anticipated trial start date	2014 Year 07 Month 23 Day
Last follow-up date	2019 Year 05 Month 22 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 06 Month 27 Day
Last modified on	2022 Year 08 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016753