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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010879
Receipt No. R000012729
Scientific Title Phase I/II study for Cold polypectomy
Date of disclosure of the study information 2013/06/10
Last modified on 2017/12/08

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Basic information
Public title Phase I/II study for Cold polypectomy
Acronym Cold polypectomy PI/II
Scientific Title Phase I/II study for Cold polypectomy
Scientific Title:Acronym Cold polypectomy PI/II
Region
Japan

Condition
Condition Colorectal polyp <10mm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of cold polypectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes PI: Incidence of tumor residue in the additional resection.
PII: Cumulative delayed bleeding rate
Key secondary outcomes PI: Incidence of spurting bleeding just after cold polypectomy. Incidence of intra-operative bleeding after EMR. R0 resection rate in cold polypectomy. adverse events.
PII: Incidence of immediate bleeding. Hemostasis during colonoscopy. R0 resection rate. adverse events. Procedure time.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cold polypectomy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) 20 y.o. <
2) Patients undergoing colorectal polypectomy
(polyps < 10mm)
3) Written Informed consent.
Key exclusion criteria 1) Polyps > 10mm
2) Patients with advanced cancer or hemorrhoid.
3) Patients with IBD, polyposis, known colon cancer.
4) Patients with anticoagulant or antiplatelet therapy. Patients with bleeding tendency.
5) Important organ failure.
6) Patient without informed consent.
7) others
Target sample size 310

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoji Takeuchi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 1-3-3 Nakamichi Higashinari-ku Osaka
TEL 06-6972-1181
Email takeuti-yo@mc.preosaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Matsumoto
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Institutional Review Board
Zip code
Address 1-3-3 Nakamichi Higashinari-ku Osaka
TEL 06-6972-1181
Homepage URL
Email matsumotochi@opho.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases, Gastrointestinal Oncology
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 06 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2013 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 05 Day
Last modified on
2017 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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