UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030790 |
|---|---|
| Receipt number | 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 | 2024/03/28 19:11:08 |
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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 | eikichi |
| Middle name | |
| Last name | ihara |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
eikichi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Minoda |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
Homepage URL
yminoda@med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university
Institute
Department
Personal name
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
KyushuUniversity
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
0926425082
byskenkyu@jimu.kyushu-u.ac.jp
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035051
