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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007418
Receipt No. R000006587
Scientific Title Development and evaluation the safety of traction clip for colorectal endoscopic submucosal dissection.
Date of disclosure of the study information 2012/03/01
Last modified on 2020/09/17

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Basic information
Public title Development and evaluation the safety of traction clip for colorectal endoscopic submucosal dissection.
Acronym The safety of traction clip for colorectal ESD.
Scientific Title Development and evaluation the safety of traction clip for colorectal endoscopic submucosal dissection.
Scientific Title:Acronym The safety of traction clip for colorectal ESD.
Region
Japan

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

Objectives
Narrative objectives1 Development and evaluate the safty of traction clip for colorectal endoscopic submucosal dissectiion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes From May 1st, 2011 to March 31, 2013
Target cases are 50.
Calcurate the interval from the date maked traction clip to colorectal ESD.
Evaluate the safty and durabillty of traction clip for colorectal ESD.
Key secondary outcomes From May 1st, 2011 to March 31, 2013
Target cases are 50.
Calcurate the interval from the date maked traction clip to colorectal ESD.
Evaluate the safty and durabillty of traction clip for colorectal ESD.

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 We study durablity and keeping quality of traction clip for colorectal ESD.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Colorectal tumor(adenoma, mucosal
carcinoma, submucosal carcinoma)
2.Indication of traction assisted
colorectal ESD
3.give informed consent
Key exclusion criteria 1.Not satisfy selection criteria
2.allergenic reaction for latex
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yuichi
Middle name
Last name Tomiki
Organization Juntendo University, Faculty of Medicine
Division name Department of Coloproctological Surgery
Zip code 2120054
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo,113-8421, Japan
TEL 03-3813-3111
Email tomiki@juntendo.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Tomiki
Organization Juntendo University
Division name Department of Coloproctological Surgery
Zip code 113-8421
Address 2-1-1,Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email tomiki@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
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 Juntendo University
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo,113-8421, Japan
Tel 0338133111
Email tomiki@juntendo.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
2012 Year 03 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
2011 Year 04 Month 01 Day
Date of IRB
2012 Year 06 Month 01 Day
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 01 Day
Last modified on
2020 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006587

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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