UMIN-CTR Clinical Trial

Basic information
Public title	Cliical study for Pharyngeal Video Scope National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2013
Acronym	NTOP2013
Scientific Title	Cliical study for Pharyngeal Video Scope National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2013
Scientific Title:Acronym	NTOP2013
Region	Japan

Condition
Condition	Any type of condition to observe oropharynx.
Classification by specialty	Medicine in general Neurology Pediatrics Oto-rhino-laryngology Oral surgery Plastic surgery Emergency medicine Intensive care medicine Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety and usefulness by a physician.
Basic objectives2	Others
Basic objectives -Others	Evaluate the safety and usefulness by patient, patient's family, nurse,Speech pathologist, and other physicians.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Determine the Safety and Efficacy 5th Grade (evaluated by physician)
Key secondary outcomes	Determine the Safety and Efficacy 5th Grade (evaluated by medical stuff and patient and patient's family) )

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients necessary to observe pharyngeal cavity.
Key exclusion criteria	could not communicate to get informed consent
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Tsunoda
Organization	National Hospital Organization Tokyo Medical Center
Division name	Artificial Organs Medical Device Creation
Zip code	152-8902
Address	2-5-1, Higashigaoka, Meguroku, Tokyo
TEL	03-3411-0111
Email	tsunodakoichi@kankakuki.go.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Tsunoda
Organization	National Hospital Organization Tokyo Medical Center
Division name	Artificial Organs Medical Device Creation
Zip code	152-8902
Address	2-5-1, Higashigaoka, Meguroku, Tokyo
TEL	03-3411-0111
Homepage URL
Email	onseishitumon@kankakuki.go.jp

Sponsor
Institute	National Hospital Organization, Nagoya Medical Center
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare.
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	e National Hospital Organization Tokyo Medical Center Research Ethics Committee
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902, Japan
Tel	03-3411-0111
Email	koichi.tsunoda@kankakuki.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	2014 Year 07 Month 18 Day

Related information
URL releasing protocol	http://doi.org/10.18926/AMO/56381
Publication of results	Published

Result
URL related to results and publications	http://doi.org/10.18926/AMO/56381
Number of participants that the trial has enrolled	150
Results	Tsunoda K, Kobayashi R, Kada A, Saito AM, Misawa H, Horibe K, Goto F, Tsunoda A, Sasaki T, Takanosawa M, Nishino H, Kondoh K, Sugiyama Y, Hisa Y. Development of an Oropharyngeal Scope with an Integrated Tongue Depressor: NTOP2013 Study. Acta Med Okayama. 2018 Dec;72(6):611-614. doi: 10.18926/AMO/56381.
Results date posted	2022 Year 12 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	(i) inpatients or outpatients who required observation and treatment of the oral cavity,palate, and pharynx
Participant flow	Evaluation by the attending doctors and display viewers (doctors and medical staffs). And Evaluation by patients and their families
Adverse events	None
Outcome measures	The primary endpoint is evaluation by the doctors who use the investigational device as an oral laryngoscope.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 07 Day
Date of IRB	2014 Year 05 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 18 Day
Last follow-up date	2015 Year 12 Month 23 Day
Date of closure to data entry	2015 Year 12 Month 23 Day
Date trial data considered complete	2015 Year 12 Month 23 Day
Date analysis concluded	2016 Year 02 Month 29 Day

Other
Other related information	Ask physicians and medical staff, alos patients and their families, to evaluate the observation, recording, moitering, susefulness, and safety.

Management information
Registered date	2014 Year 07 Month 18 Day
Last modified on	2022 Year 12 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016970