UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034979
Receipt No. R000039595
Scientific Title A prospective exploratory study on the evaluation of saline injection effectiveness for cold snare polypectomy
Date of disclosure of the study information 2018/11/25
Last modified on 2019/05/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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/ctr_e/ctr_view.cgi?recptno=R000039595

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.