UMIN-CTR Clinical Trial

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