UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036279
Receipt number R000041319
Scientific Title Feasibility of for measure of intestinal blood flow by Laser Speckle Flowgraphy
Date of disclosure of the study information 2019/04/01
Last modified on 2024/03/26 16:25:00

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Basic information

Public title

Feasibility of for measure of intestinal blood flow by Laser Speckle Flowgraphy

Acronym

Feasibility of for measure of intestinal blood flow by LSFG

Scientific Title

Feasibility of for measure of intestinal blood flow by Laser Speckle Flowgraphy

Scientific Title:Acronym

Feasibility of for measure of intestinal blood flow by LSFG

Region

Japan


Condition

Condition

colorectal disease

Classification by specialty

Surgery in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

we evaluate feasibility for measure of intestinal blood flow by Laser Speckle Flowgraphy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Is there a difference between the blood flow border obtained by LSFG and the intestinal vascular processing point

Key secondary outcomes

Is there a difference between the blood flow border obtained by LSFG and the border obtained by Fluorescence imaging with indocyanine green (ICG)


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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Measurement is only once and the standerd measuring time is 12s(4s,3times)during operation.Drug is not need.

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

Patients who obtained consent in adults over 20

Key exclusion criteria

Patients who cannot afford extended surgery because of severe comorbidities

Patients who need immediate completion of surgery due to intraoperative complications such as bleeding

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tomoaki
Middle name
Last name Kaneko

Organization

Toho University Omori Medical Center

Division name

Department of gastroenterological surgery

Zip code

143-0015

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo , Japan

TEL

03-3762-4151

Email

tomoaki.kaneko@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Tomoaki
Middle name
Last name Kaneko

Organization

Toho University Omori Medical Center

Division name

Department of gastroenterological surgery

Zip code

143-0015

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo , Japan

TEL

03-3762-4151

Homepage URL


Email

tomoaki.kaneko@med.toho-u.ac.jp


Sponsor or person

Institute

Toho university

Institute

Department

Personal name



Funding Source

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toho University Omori Medical Center

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo , Japan

Tel

03-3762-4151

Email

tomoaki.kaneko@med.toho-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

2019 Year 04 Month 01 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

Open public recruiting

Date of protocol fixation

2017 Year 10 Month 04 Day

Date of IRB

2017 Year 11 Month 29 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2023 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 23 Day

Last modified on

2024 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041319


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name