UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048661 |
|---|---|
| Receipt number | R000055450 |
| Scientific Title | Clinical trial for the comparison between low and high concentrated Injection Solution Ability for Colorectal endoscopic submucosal dissection: ISAC study |
| Date of disclosure of the study information | 2022/08/13 |
| Last modified on | 2023/12/31 15:10:34 |
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Basic information
Public title
Clinical trial for the comparison between low and high concentrated Injection Solution Ability for Colorectal endoscopic submucosal dissection: ISAC study
Acronym
ISAC study
Scientific Title
Clinical trial for the comparison between low and high concentrated Injection Solution Ability for Colorectal endoscopic submucosal dissection: ISAC study
Scientific Title:Acronym
ISAC study
Region
| Japan |
Condition
Condition
colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the difference of procedure time between high-concentrated and low-cencetrated injection solution n colorectal ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of ESD procedure time between high-concentrated and low-cencetrated injection solution
Key secondary outcomes
The comparison of various therapeutic results between two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
high-concentrated injection solution
Interventions/Control_2
low-concentrated injection solution
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
A patient scheduled ESD for colorectal malignant tumors
Key exclusion criteria
1) FAP
2) IBD
3) severe disease of other organs
Target sample size
164
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural Univedrsity of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
naohisa@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural Univedrsity of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural Univedrsity of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural Univedrsity of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kyoto prefectural univeristy of medicine
Address
Kajii-cho 465, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
1. 長崎大学 (長崎県)
2. 西陣病院 (京都府)
3. 京都第一赤十字病院 (京都府)
4. 愛生会山科病院 (京都府)
5. 綾部市立病院 (京都府)
6．済生会京都病院 (京都府)
7. 京都府立医科大学(京都府)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 13 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055450
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| Registered date | File name |
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