UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025520
Receipt number R000029298
Scientific Title Diffuse optical tomography for neonates and infants: development of image reconstruction algorithms
Date of disclosure of the study information 2017/01/10
Last modified on 2022/07/12 10:05:20

* 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

Diffuse optical tomography for neonates and infants: development of image reconstruction algorithms

Acronym

Development of diffuse optical tomography

Scientific Title

Diffuse optical tomography for neonates and infants: development of image reconstruction algorithms

Scientific Title:Acronym

Development of diffuse optical tomography

Region

Japan


Condition

Condition

low birth infants

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical applications of diffuse optical tomography in Pediatrics.

Basic objectives2

Others

Basic objectives -Others

Verification of the image reconstruction algorithms and evaluation of instrumental performance.

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Qualification of reconstructed images

Key secondary outcomes

Qualification of measurement procedures


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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Measurements with 8ch time-resolved spectroscopy using ultra-short pulsed lasers(twice with an interval of a few days)

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

14 days-old <=

Age-upper limit

180 days-old >

Gender

Male and Female

Key inclusion criteria

Healthy low birth infants who are supposed to be discharged within 14 weeks.

Key exclusion criteria

Neurological abnormalities

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yoko
Middle name
Last name Hoshi

Organization

Hamamatsu University School of Medicine

Division name

Preeminent Medical Photonics Education & Research Center, Department of Biomedical Optics

Zip code

431-3192

Address

1-20-1 Handayama Higashiku, Hamamatsu

TEL

053-435-2329

Email

yhoshi@hama-med.ac.jp


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Hoshi

Organization

Hamamatsu University School of Medicine

Division name

Preeminent Medical Photonics Education & Research Center, Department of Biomedical Optics

Zip code

431-3192

Address

1-20-1 Handayama Higashiku, Hamamatsu

TEL

053-435-2329

Homepage URL


Email

yhoshi@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatrsu Univeristy School of Medicine

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama Higashi-ku, Hamamatsu

Tel

053-435-2111

Email

rinri@hama-med.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

2017 Year 01 Month 10 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

Completed

Date of protocol fixation

2016 Year 11 Month 01 Day

Date of IRB

2017 Year 01 Month 10 Day

Anticipated trial start date

2017 Year 01 Month 10 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 01 Month 04 Day

Last modified on

2022 Year 07 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029298


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name