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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031425
Receipt No. R000035884
Scientific Title Clip on Clip Closure Method (CCCM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Date of disclosure of the study information 2018/03/01
Last modified on 2019/02/23

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Basic information
Public title Clip on Clip Closure Method (CCCM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Acronym CCCM for mucosal defect after gastric endoscopic submucosal dissection
Scientific Title Clip on Clip Closure Method (CCCM) for mucosal defect after gastric endoscopic submucosal dissection: a prospective study
Scientific Title:Acronym CCCM for mucosal defect after gastric endoscopic submucosal dissection
Region
Japan

Condition
Condition early gastric cancer and gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy and safety of Clip on Clip Closure Method (CCCM) in mucosal defect closure after ESD of gastric adenoma and early gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Evaluate whether mucosal defect after ESD is closed by Clip on Clip Closure Method using conventional clip.
Key secondary outcomes

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
Device,equipment
Interventions/Control_1 For mucosal defect after ESD, only conventional clips are used and closed using Clip on Clip Closure Method.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Early gastric cancer and adenoma suitable for ESD. Cases with written and oral informed consent are included.
Key exclusion criteria Cases with severe complications are excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Oyamada Jun
Organization Ise Red Cross Hospital
Division name Gastroenterology
Zip code
Address 1-471-2 Funae, Ise, Mie, Japan 516-8512
TEL 0596-28-2171
Email oyamada1398@cocoa.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nomura Tatsuma
Organization Kinan Hospital
Division name Internal medicine, Gastroenterology
Zip code
Address 4750 Atawa, Mihama, Minamimuro, Mie 519-5293, Japan
TEL 05979-2-1333
Homepage URL
Email m06076tn@icloud.com

Sponsor
Institute Ise Red Cross Hospital
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 伊勢赤十字病院(三重),市立四日市病院(三重),医療法人山下病院(愛知)

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 Completed
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 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
2018 Year 02 Month 22 Day
Last modified on
2019 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035884

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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