UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of dualoop in endoscopic mucosal resection to colorectal polyps
Title of the study (Brief title)	The efficacy of dualoop in colorectal EMR
Region	Japan

Condition
Condition	colorectal polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the dualoop in colorectal endoscopic mucosal resection
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of complete resection, enbloc resection.
Key secondary outcomes	The rate of postoperative hemorrhage and perforation

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	colorectal polyp mesuring 5-30 mm in diameter
Key exclusion criteria	cases with severe general conditions
Target sample size	200

Research contact person
Name of lead principal investigator	Naohisa Yoshida
Organization	Kyoto Prefectural University of Medcine
Division name	Department of molecular gastroenterology and hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kyoto Prefectural University of Medcine
Division name	Department of molecular gastroenterology and hepatology
Address
TEL	075-251-5519
Homepage URL
Email

Sponsor
Institute	Department of molecular gastroenterology and hepatology, Kyoto Prefectural University of Medcine
Institute
Department

Funding Source
Organization	Department of molecular gastroenterology and hepatology, Kyoto Prefectural University of Medcine
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	2013 Year 03 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 09 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	random sampling

Management information
Registered date	2013 Year 03 Month 03 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011889