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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030068
Receipt No. R000034334
Scientific Title A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/21

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Basic information
Public title A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size
Acronym Device selection RCT in colorectal ESD (NANO STUDY)
Scientific Title A randomized control trial of efficacy of endoscopic submucosal dissection using an ITknife nano for colorectal neoplasms larger than 30 mm in size
Scientific Title:Acronym Device selection RCT in colorectal ESD (NANO STUDY)
Region
Japan

Condition
Condition colorectal epitherial neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of ITknife nano compared with Dual knife in colorectal ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Procedure time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Dual knife group
Interventions/Control_2 ITknife nano group
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) Patients who receive colorectal ESD
2) Colorectal epitherial neoplasms which are larger than 30 mm and smaller than 50 mm
3) Laterally spreading tumor (LST)
4) Written informed consent
Key exclusion criteria 1) cT1b(SM) cancer
2) non-LST lesions
3) Local recurrences/ Scar lesions
4) Easy bleeding disorder
5) Impossible to suspend anticoagulant or antiplatelet medications
6) Women during pregnancy
7) Inappropriate cases by investigators
Target sample size 216

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kinichi Hotta
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Email k.hotta@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayo Ito
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Homepage URL
Email sa.ito@scchr.jp

Sponsor
Institute Division of Endoscopy, Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Division of Endoscopy, Shizuoka Cancer Center
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
2017 Year 12 Month 01 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
2017 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 21 Day
Last modified on
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034334

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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