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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030790
Receipt No. R000035051
Scientific Title An analysis of electrical impidance for the gastrointestinal submucosal tumor (SMT)
Date of disclosure of the study information 2018/01/12
Last modified on 2018/06/16

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Basic information
Public title An analysis of electrical impidance for the gastrointestinal submucosal tumor (SMT)
Acronym An analysis of impidance for the gastrointestinal SMT
Scientific Title An analysis of electrical impidance for the gastrointestinal submucosal tumor (SMT)
Scientific Title:Acronym An analysis of impidance for the gastrointestinal SMT
Region
Japan

Condition
Condition Submucosal tumor of gastrointestine
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate diagnostic yield for SMT using the probe,which can calcurate electrical impidance of the tissue through the endoscopic channnel.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnosic yield using electrical impedance level for GIST
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 Using tissue Conductance Meter for the patient with SMT
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. Patients who are diagnosed SMT and undergo endoscopic mucosal incision assisted biopsy.
2. Patients from whom written informed consent is obtained.
3. Patients who are older than 20 years old.
Key exclusion criteria 1. Patients who are judged as contraindication for endoscopy.
2. Patients who are implanted Cardiac Pacemaker.
3. Patients who are judged as being inappropriate for this study by their medical doctor.
4. Patients from whom written informed consent is not obtained.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eikichi Ihara
Organization Kyushu University Graduate School of Medical Sciences
Division name Department of Medicine and Bioregulatory Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5286
Email eikichi@intmed3.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Minoda
Organization Kyushu University Graduate School of Medical Sciences
Division name Department of Medicine and Bioregulatory Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5286
Homepage URL
Email yminoda@med.kyushu-u.ac.jp

Sponsor
Institute kyushu university
Institute
Department

Funding Source
Organization kyushu university
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 01 Month 12 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 12 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 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 01 Month 12 Day
Last modified on
2018 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035051

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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