UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic resection of early GI tract tumor using the Clutch Cutter
Title of the study (Brief title)	Clinical research using the Clutch Cutter
Region	Japan

Condition
Condition	early GI tract tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of usefullness of endoscopic resection using the Clutch Cutter for ki
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	R0 resection rate Complication rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	early GI tract tumo
Key exclusion criteria	Advanced GI cancer
Target sample size	2000

Research contact person
Name of lead principal investigator	Kazuya Akahoshi
Organization	Aso Iizuka Hospital
Division name	Gastroenterology
Address	3-83 Yoshio, Iizuka, Japan
TEL	0948-22-3800
Email	kakahoshi2@aol.com

Public contact
Name of contact person	Kazuya Akahoshi
Organization	Aso Iizuka Hospital
Division name	Gastroenterology
Address	3-83 Yoshio, Iizuka, Japan
TEL	0948-22-3800
Homepage URL
Email	kakahoshi2@aol.com

Sponsor
Institute	Aso Iizuka Hospital
Institute
Department

Funding Source
Organization	Aso Iizuka Hospital
Organization
Division
Category of Funding Organization	Other
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	2018 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 07 Month 01 Day
Anticipated trial start date	2007 Year 07 Month 25 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	Partially published
URL releasing results
Results
Other related information	Observational study Clinical outcome

Management information
Registered date	2018 Year 12 Month 17 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024640