UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014396
Receipt number R000016753
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
Date of disclosure of the study information 2014/08/18
Last modified on 2022/08/26 08:35:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name