UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Non-contact Brain Activity Sensing System to Measure Stress during Endoscopy
Title of the study (Brief title)	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	Hajime Isomoto
Organization	Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University
Division name	Division of Medicine and Clinical Science
Address	36-1, Nishi-cho, Yonago, 683-8504, Japan
TEL	0859-38-6745
Email	isomoto@med.tottori-u.ac.jp

Public contact
Name of contact person	Masashi Fujii
Organization	Tottori University Hospital
Division name	Advanced Medicine, Innovation and Clinical Research Center
Address	36-1, Nishi-cho, Yonago, 683-8504, Japan
TEL	0859-38-6745
Homepage URL	http://www2.hosp.med.tottori-u.ac.jp/
Email	fujii-masashi@jptecman.com

Sponsor
Institute	Tottori University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039963