UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clip on Clip Closure Method (CCCM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Title of the study (Brief title)	CCCM for mucosal defect after gastric endoscopic submucosal dissection
Region	Japan

Condition
Condition	early gastric cancer and gastric adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy and safety of Clip on Clip Closure Method (CCCM) in mucosal defect closure after ESD of gastric adenoma and early gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Evaluate whether mucosal defect after ESD is closed by Clip on Clip Closure Method using conventional clip.
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	Device,equipment
Interventions/Control_1	For mucosal defect after ESD, only conventional clips are used and closed using Clip on Clip Closure Method.
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	Early gastric cancer and adenoma suitable for ESD. Cases with written and oral informed consent are included.
Key exclusion criteria	Cases with severe complications are excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Oyamada Jun
Organization	Ise Red Cross Hospital
Division name	Gastroenterology
Address	1-471-2 Funae, Ise, Mie, Japan 516-8512
TEL	0596-28-2171
Email	oyamada1398@cocoa.plala.or.jp

Public contact
Name of contact person	Nomura Tatsuma
Organization	Kinan Hospital
Division name	Internal medicine, Gastroenterology
Address	4750 Atawa, Mihama, Minamimuro, Mie 519-5293, Japan
TEL	05979-2-1333
Homepage URL
Email	m06076tn@icloud.com

Sponsor
Institute	Ise Red Cross Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	伊勢赤十字病院（三重），市立四日市病院（三重），医療法人山下病院（愛知）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 22 Day
Last modified on	2019 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035884