UMIN-CTR Clinical Trial

Basic information
Public title	A prospective exploratory study on the evaluation of saline injection effectiveness for cold snare polypectomy
Acronym	Effectiveness of saline injection of cold snare polypectomy
Scientific Title	A prospective exploratory study on the evaluation of saline injection effectiveness for cold snare polypectomy
Scientific Title:Acronym	Effectiveness of saline injection of cold snare polypectomy
Region	Japan

Condition
Condition	colon polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Histological analysis of the specimens resected by conventional cold snare polypectomy or cold snare polypectomy using saline injection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Histological analysis of resected specimens
Key secondary outcomes	The incidence of delayed bleeding The incidence of delayed perforation The incidence of immediate bleeding Other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Conventional cold polypectomy
Interventions/Control_2	Cold polypectomy with saline injection
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	1) 20 years old and older 2) Polyps less than 10 mm in diameter 3) Written informed consent
Key exclusion criteria	1) Polyps suspected of being cancers 2) Others
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Yuji Middle name Last name Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology
Zip code	6028566
Address	Kajii-cho465, Kamigyo-ku, Kyoto
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
1st name of contact person	1st name Akihito Middle name Last name Harusato
Organization	Kyoto Prefectural University of Medicine
Division name	North Medical Center, Department of Gastroenterology
Zip code	6292261
Address	Otokoyama 481, Yosano, Kyoto, Japan
TEL	0772-46-3371
Homepage URL
Email	harup@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuchiyama City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine
Address	Kajii-cho 465, Kamigyo-ku, Kyoto city
Tel	075-251-5337
Email	rinri@koto.kpu-m.ac.jp

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	京都府立医科大学及び附属北部医療センター、市立福知山市民病院

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 21 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 11 Month 26 Day
Last follow-up date	2021 Year 11 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 22 Day
Last modified on	2019 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039595