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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032204
Receipt No. R000036727
Scientific Title New marking method to detect localization of gastrointestinal tumor
Date of disclosure of the study information 2018/04/11
Last modified on 2018/04/11

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Basic information
Public title New marking method to detect localization of gastrointestinal tumor
Acronym New marking method for gastrointestinal tumor
Scientific Title New marking method to detect localization of gastrointestinal tumor
Scientific Title:Acronym New marking method for gastrointestinal tumor
Region
Japan

Condition
Condition Gastrointestinal tumor
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a new marking method using an endoscopic clip with a marking device and power source device by electromagnetic power transfer to detect the accurate location of the site of interest
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate a new marking by detecting the marker placed before surgery
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 new marker
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
79 years-old >=
Gender Male and Female
Key inclusion criteria Patients who will undergo gastrointestinal suregry
Key exclusion criteria None
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norikatsu Miyoshi
Organization Osaka International Cancer Institute
Division name Surgery
Zip code
Address 3-1-69, Ohtemae, Chuo-ku, Osaka, 541-8567
TEL 06-6945-1181
Email miyosi-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norikatsu Miyoshi
Organization Osaka International Cancer Institute
Division name Surgery
Zip code
Address 3-1-69, Ohtemae, Chuo-ku, Osaka, 541-8567
TEL 06-6945-1181
Homepage URL
Email miyosi-no@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Scholarship donation
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
2018 Year 04 Month 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 02 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 04 Month 11 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036727

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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