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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011548
Receipt No. R000013496
Scientific Title A novel hemostatic agent in endoscopic mucosal resection and endoscopic submucosal dissection
Date of disclosure of the study information 2013/08/21
Last modified on 2018/08/25

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Basic information
Public title A novel hemostatic agent in endoscopic mucosal resection and endoscopic submucosal dissection
Acronym A novel hemostatic agent in EMR and ESD
Scientific Title A novel hemostatic agent in endoscopic mucosal resection and endoscopic submucosal dissection
Scientific Title:Acronym A novel hemostatic agent in EMR and ESD
Region
Japan

Condition
Condition Early stage gastrointestinal cancer and adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety and efficacy of a novel hemostatic agent in endoscopic resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post-procedure bleeding
Key secondary outcomes healing of defect after the procedure

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
Medicine
Interventions/Control_1 hemostatic agents
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo endoscopic resection for early esophageal, gastric and colorectal cancers or adenomas.
Key exclusion criteria Difficult cases including hematologic disease for endoscopic resection.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Uraoka
Organization Keio University School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3437
Email turaoka@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Uraoka
Organization Keio University School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3437
Homepage URL
Email turaoka@a3.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 08 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially 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 Completed
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 29 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
2013 Year 08 Month 21 Day
Last modified on
2018 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013496

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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