UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046590 |
|---|---|
| Receipt number | R000053147 |
| Scientific Title | Evaluation of utility and safety of endoscopic submucosal dissection using multi loop traction device for early colorectal cancer-single center prospective observational study- |
| Date of disclosure of the study information | 2022/01/11 |
| Last modified on | 2023/01/10 10:32:57 |
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Basic information
Public title
Evaluation of utility and safety of endoscopic submucosal dissection using multi loop traction device for early colorectal cancer-single center prospective observational study-
Acronym
Evaluation of utility and safety of endoscopic submucosal dissection using multi loop traction device for early colorectal cancer-single center prospective observational study-
Scientific Title
Evaluation of utility and safety of endoscopic submucosal dissection using multi loop traction device for early colorectal cancer-single center prospective observational study-
Scientific Title:Acronym
Evaluation of utility and safety of endoscopic submucosal dissection using multi loop traction device for early colorectal cancer-single center prospective observational study-
Region
| Japan |
Condition
Condition
Early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Multi-loop traction device (MLTD) is a traction device that can be delivered by TTS (through the scope) and can adjust the traction range and add traction. MLTD is a device that is expected to simplify the procedure of endoscopic submucosal dissection (ESD) and to safely complete ESD even for trainees who have few endoscopic treatments and are not very skilled. The purpose was to examine the safety and efficacy of colorectal ESD under MTLD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic findings (visual type, localization, size)
Details of the endoscopic treatment (operator, ESD knife, contents of the injection solution, treatment time)
Adverse event
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with preoperative colonoscopy and endoscopic diagnosis or histopathological diagnosis of early colorectal cancer with a predicted depth of Tis to T1a.
(2)Patients who have given their free written consent.
Key exclusion criteria
(1) Patients whose treatment is recurrent or residual lesions of early-stage colorectal cancer.
(2) Patients with early colorectal cancer extending to the appendix opening or diverticulum.
(3) Patients with early colorectal cancer that extends to the small intestine or anal canal.
(4) Patients who are judged by the principal investigator and the research coordinator to be inappropriate for participation in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akinari |
| Middle name | |
| Last name | Takao |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Gastroenterology
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
0338232101
globes.and.maps.1228@gmail.com
Public contact
Name of contact person
| 1st name | Akinari |
| Middle name | |
| Last name | Takao |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Gastroenterology
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
0338232101
Homepage URL
globes.and.maps.1228@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
Tel
0338232101
rinri@cick.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
| 2022 | Year | 01 | Month | 11 | 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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will be observed for one week for any adverse events.
Management information
Registered date
| 2022 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053147
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
