UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and efficacy for endoscopic biopsy using thin forceps
Title of the study (Brief title)	Safety and efficacy of thin forceps
Region	Japan

Condition
Condition	Neoplasms in upper GI tract
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy of thin biopsy forceps compared to normal biopsy forceps
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of specimens which can be evaluated appropriately.
Key secondary outcomes	Endoscopic bleeding time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Endoscopic biopsy using thin forceps normal forceps
Interventions/Control_2	Endoscopic biopsy using normal forceps
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	(A)Scheduled endoscopic treatment of neoplasms in stomach or esophagus. (B)Neoplasm gross type is 0-IIa/IIb/IIc. (C)Demarcation line is detectable. (D)Informed consent. (E)Performance status(ECOG):0-2.
Key exclusion criteria	(A)Severe hematological, hepatological, or renal disorder accompanied with hemorrhagic tendency. (B)Other severe comorbidities. (C)During anticancer chemotherapy. (D)Poor compliance.
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Ono
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL	03-3815-5411
Email	satoshi-tky@umin.ac.jp

Public contact
Name of contact person	Satoshi Ono
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, BUnkyo-ku, Tokyo.
TEL	03-3815-5411
Homepage URL
Email	satoshi-tky@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology, the University of Tokyo Hospital.
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
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	2013 Year 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 08 Day
Anticipated trial start date	2013 Year 07 Month 08 Day
Last follow-up date	2014 Year 07 Month 31 Day
Date of closure to data entry	2014 Year 07 Month 31 Day
Date trial data considered complete	2014 Year 08 Month 31 Day
Date analysis concluded	2014 Year 10 Month 30 Day

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

Management information
Registered date	2013 Year 07 Month 07 Day
Last modified on	2018 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013045