UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of new bipolar hemostatic forceps for endoscopic resection
Title of the study (Brief title)	The efficacy of new hemostatic forceps for ER
Region	Japan

Condition
Condition	the gastrointestinal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficasy of new bipolar hemostatic forceps for bleeding during endoscopic resection of the GI tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the successful rate of hemostasis
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	new bipolar hamostatic forceps
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient for gastrointestinal tumor and subjected to endoscopic resection.
Key exclusion criteria	Patient who judged that we were inappropriate to perform examination safely.
Target sample size	10

Research contact person
Name of lead principal investigator	Naohisa Yahagi
Organization	Keio University
Division name	Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-3437
Email	yahagi-tky@umin.ac.jp

Public contact
Name of contact person	Yasutoshi Ochiai
Organization	Keio University
Division name	Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-3437
Homepage URL
Email	yochiai.a7@keio.jp

Sponsor
Institute	Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Institute
Department

Funding Source
Organization	Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
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	2016 Year 10 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 22 Day
Anticipated trial start date	2016 Year 10 Month 13 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	2016 Year 10 Month 12 Day
Last modified on	2017 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028063