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
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
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
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
