UMIN-CTR Clinical Trial

Basic information
Public title	The development of a new treatment for mucosal suture after endoscopic mucosal resection
Acronym	ECL trial
Scientific Title	Prospective observational trial for the development of a new treatment for mucosal suture after endoscopic mucosal resection
Scientific Title:Acronym	ECL trial
Region	Japan

Condition
Condition	early state gastrointestinal neoplasia
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate efficacy and safety of a new endoscopic suture technique after endoscopic resection for early stage gastrointestinal neoplasia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of complete suture
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	EMR
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.The patients who undergo ESD for early stage gastrointestinal neoplasia (stomach, duodenum and colon) in our hospital. 2.The patients who accepted to written informed consent on this study.
Key exclusion criteria	1.Without written informed consent. 2.THe patients judged inappropriate for this study by the physicians.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Hashimoto
Organization	School of Medicine, Niigata University
Division name	Department of Preemptive Medicine for Digestive Diseases and Healthy Active Life
Zip code	951-8510
Address	1-757 Asahimachidori, Chuoku, Niigata, Japan
TEL	+81-25-227-2207
Email	hashim@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Hashimoto
Organization	School of Medicine, Niigata University
Division name	Department of Preemptive Medicine for Digestive Diseases and Healthy Active Life
Zip code	951-8510
Address	1-757 Asahimachidori, Chuoku, Niigata, Japan
TEL	+81-25-227-2207
Homepage URL
Email	hashim@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee of Niigata University
Address	1-757 Asahimachidori, Chuoku, Niigata, Japan
Tel	025-227-2625
Email	sanonao@adm.niigata-u.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	2019 Year 10 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	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 07 Month 22 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2022 Year 03 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042967