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 UMIN000041718
Receipt No. R000047619
Scientific Title Validation of the forced cold snare polypectomy (FCSP)
Date of disclosure of the study information 2020/09/10
Last modified on 2020/09/14

* 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 Validation of the forced cold snare polypectomy (FCSP)
Acronym Validation of the forced cold snare polypectomy (FCSP)
Scientific Title Validation of the forced cold snare polypectomy (FCSP)
Scientific Title:Acronym Validation of the forced cold snare polypectomy (FCSP)
Region
Japan

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

Objectives
Narrative objectives1 Validation of the forced cold snare polypectomy (FCSP)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of the forced cold snare polypectomy
Key secondary outcomes The complication rate of the forced cold snare polypectomy
The predictors for the forced cold snare polypectomy
The risk factors for protrusions within the cold snare defect (CSDPs)

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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with colorectal polyps were consequentially enrolled in the present study.
Key exclusion criteria Patients whose lesions were found to be outside the guideline or expanded criteria for CSP by the endoscopic characteristics and histological findings of biopsy specimens.

Patients in disagreement with informed consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Arimoto
Organization Omori Red Cross Hospital
Division name Department of Gastroenterology
Zip code 143-8527
Address 4-30-1 Chuou Ohta-ku, Tokyo 143-8527, Japan
TEL +81-3-3775-3111
Email junarimoto_junjun@yahoo.co.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Arimoto
Organization Omori Red Cross Hospital
Division name Department of Gastroenterology
Zip code 143-8527
Address 4-30-1 Chuou Ohta-ku, Tokyo 143-8527, Japan
TEL +81-3-3775-3111
Homepage URL
Email junarimoto_junjun@yahoo.co.jp

Sponsor
Institute Omori Red Cross Hospital
Department of Gastroenterology
Institute
Department

Funding Source
Organization This study do not need financial support
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Omori Red Cross Hospital
Address 4-30-1 Chuou Ohta-ku, Tokyo 143-8527, Japan
Tel +81-3-3775-3111
Email junarimoto_junjun@yahoo.co.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 大森赤十字病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 10 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
2020 Year 09 Month 07 Day
Date of IRB
2020 Year 08 Month 24 Day
Anticipated trial start date
2020 Year 09 Month 11 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 01 Month 31 Day

Other
Other related information Observational study about validation of forced cold snare polypectomy.

The target lesion is adaptive lesion for colorectal CSP.

Management information
Registered date
2020 Year 09 Month 07 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.