UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A novel hemostatic agent in endoscopic mucosal resection and endoscopic submucosal dissection
Title of the study (Brief title)	A novel hemostatic agent in EMR and ESD
Region	Japan

Condition
Condition	Early stage gastrointestinal cancer and adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of a novel hemostatic agent in endoscopic resection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post-procedure bleeding
Key secondary outcomes	healing of defect after the procedure

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	Medicine
Interventions/Control_1	hemostatic agents
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who undergo endoscopic resection for early esophageal, gastric and colorectal cancers or adenomas.
Key exclusion criteria	Difficult cases including hematologic disease for endoscopic resection.
Target sample size	200

Research contact person
Name of lead principal investigator	Toshio Uraoka
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3437
Email	turaoka@a3.keio.jp

Public contact
Name of contact person	Toshio Uraoka
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3437
Homepage URL
Email	turaoka@a3.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	2013 Year 08 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 29 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

Management information
Registered date	2013 Year 08 Month 21 Day
Last modified on	2018 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013496