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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046590
Receipt No. 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 2022/07/12

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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
Email 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
Email globes.and.maps.1228@gmail.com

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

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
Email 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
2024 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
2022 Year 07 Month 12 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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