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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044671
Receipt No. R000051017
Scientific Title New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Date of disclosure of the study information 2021/06/28
Last modified on 2021/06/26

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Basic information
Public title New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Acronym New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Scientific Title New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Scientific Title:Acronym New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Region
Japan

Condition
Condition Colorectal tumors
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Consider positively the effectiveness, safety and realizability of the new strategy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effectiveness of new strategy
Key secondary outcomes

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
Maneuver
Interventions/Control_1 Endoscopic suture
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 Those who can receive endoscopic submucosal exfoliation of colon tumors at our hospital in the future

Key exclusion criteria (1) Patients with lesions near denture lines and anastomosis
(2) Patients with lesions extending to the end of the ileum
(3) Minors (under 20 years old)
(4) Pregnant patients
(5) Other patients deemed unsuitable as subjects by the research manager
(6) Patients with lesions of 70 mm or more in size

Target sample size 40

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Abiko
Organization Hakodate Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 0418680
Address 1-Chome Minato-chou
TEL 0138432000
Email abiko1982@gmail.com

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Abiko
Organization Hakodate Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 041-8680
Address 1-Chome Minato-chou
TEL 0138432000
Homepage URL
Email abiko1982@gmail.com

Sponsor
Institute Hakodate Municipal Hospital
Institute
Department

Funding Source
Organization Japanese Gastroenterological Endoscopy Society Hokkaido Branch
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hakodate Municipal Hospital
Address 1-Chome Minato-chou
Tel 0138432000
Email abiko1982@gmail.com

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
2021 Year 06 Month 28 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
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 04 Month 20 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2023 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 26 Day
Last modified on
2021 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051017

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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