UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035052 |
|---|---|
| Receipt number | R000039963 |
| Scientific Title | Evaluation of Non-contact Brain Activity Sensing System to Measure Stress during Endoscopy |
| Date of disclosure of the study information | 2018/12/14 |
| Last modified on | 2018/11/28 16:03:37 |
* 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
Evaluation of Non-contact Brain Activity Sensing System to Measure Stress during Endoscopy
Acronym
Evaluation of Non-contact Brain Activity Sensing System to Measure Stress during Endoscopy
Scientific Title
Evaluation of Non-contact Brain Activity Sensing System to Measure Stress during Endoscopy
Scientific Title:Acronym
Evaluation of Non-contact Brain Activity Sensing System to Measure Stress during Endoscopy
Region
| Japan |
Condition
Condition
Digestive disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Non-contact brain activity sensing system was developed to be able to measure brain activity level estimated from measurement results of cerebral blood flow rate. The purpose of this study is to clarify the effectiveness of the system by investigating correlation between the brain activity level measured using this system and the patient's pain during the endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Brain activity level measured by non-contact brain activity sensing system
2. Measurement results of amylase in salivary
3. Stress level defined by measurement results of grasp force
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients who were needed and scheduled endoscopy or endoscopic treatment provided by health insurance
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
Patients who were needed and scheduled endoscopy or endoscopic treatment provided by health insurance
Key exclusion criteria
Patients who were determined by their doctors or lead principal investigator to be inappropriate for research subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University
Division name
Division of Medicine and Clinical Science
Zip code
Address
36-1, Nishi-cho, Yonago, 683-8504, Japan
TEL
0859-38-6745
isomoto@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Tottori University Hospital
Division name
Advanced Medicine, Innovation and Clinical Research Center
Zip code
Address
36-1, Nishi-cho, Yonago, 683-8504, Japan
TEL
0859-38-6745
Homepage URL
http://www2.hosp.med.tottori-u.ac.jp/
fujii-masashi@jptecman.com
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 12 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | 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 | 11 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039963
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
