UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Title of the study (Brief title)	Utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection
Region	Japan

Condition
Condition	gastric tumor(early gastric cancer, gastric adenoma), colorectal tumor(early colorectal cancer, colorectal adenoma)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the utility of lens coating with liquid ceramic for gastrointestinal endoscopic submucosal dissection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visibility(every 15 minutes and the end of procedure)
Key secondary outcomes	procedure time, number of withdrawal of endoscopy during procedure and adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	ESD using endoscope coated with liquid ceramic
Interventions/Control_2	ESD using conventional endoscope
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.Patients who undergo endoscopic submucosal dissecion. 2.Patients who were eligible to this study criteria with written informed consent signed and dated.
Key exclusion criteria	Cases with severe complications are excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	Hattori Masashi
Organization	Medical corporation Yamashita Hospital
Division name	Gastroenterology
Address	1-3-5, Nakamachi, Ichinomiya
TEL	0586-45-4511
Email	m.hattori@yamashita.or.jp

Public contact
Name of contact person	Yoshikawa Masakatsu
Organization	Medical corporation Yamashita Hospital
Division name	Gastroenterology
Address	1-3-5, Nakamachi, Ichinomiya
TEL	0586-45-4511
Homepage URL
Email	m.yoshikawa@yamashita.or.jp

Sponsor
Institute	Medical corporation Yamashita Hospital
Institute
Department

Funding Source
Organization	Medical corporation Yamashita Hospital
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 11 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	2017 Year 11 Month 01 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033952