UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042093 |
|---|---|
| Receipt number | R000047985 |
| Scientific Title | Relationship between the gastrointestinal dysmotility and electrical action potential of the gastrointestinal tract |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2024/03/28 19:14:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between gastrointestinal dysmotility and electrical action potential of the gastrointestinal tract
Acronym
Relationship between the gastrointestinal dysmotility and electrical action potential of the gastrointestinal tract
Scientific Title
Relationship between the gastrointestinal dysmotility and electrical action potential of the gastrointestinal tract
Scientific Title:Acronym
Relationship between the gastrointestinal dysmotility and electrical action potential of the gastrointestinal tract
Region
| Japan |
Condition
Condition
gastrointestinal dysmotility
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the relationship between gastrointestinal dysmotility and electrical action potential of the gastrointestinal tract
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether electrical action potentials and waveforms are associated with each disease of gastrointestinal dysmotility
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the device to evaluate electrical action potential of gastrointestinal tract for the patient
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 suspected of gastrointestinal dysmotility and undergoing endoscopic examination
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 judged as being inappropriate for this study by their medical doctor.
3. Patients from whom written informed consent is not obtained.
Target sample size
190
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 gastroenterolgy and metabolism
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
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
minokichi7@hotmail.com
Sponsor or person
Institute
kyushu university
Institute
Department
Personal name
Funding Source
Organization
Terumo life science foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu university
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
81926425082
0926425082
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
| 2020 | Year | 10 | Month | 14 | 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
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2020 | Year | 10 | 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=R000047985
