UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study for Pharyngeal Video Scope Type-2 National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2016
Acronym	NTOP2016
Scientific Title	Clinical study for Pharyngeal Video Scope Type-2 National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2016
Scientific Title:Acronym	NTOP2016
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the safety and usefulness by the physician, medical stuff, and patients and patient's families.
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	Not applicable
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 from patients or their guardians.
Target sample size	100

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

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

Sponsor
Institute	National Hospital Organization, Nagoya Medical Center
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	国立病院機構　東京医療センター 国立病院機構　名古屋医療センター（予定）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 29 Day

Related information
URL releasing protocol	https://doi.org/10.2739/kurumemedj.MS644003
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.2739/kurumemedj.MS644003
Number of participants that the trial has enrolled	100
Results	Tsunoda K, Kobayashi R, Kada A, M Saito A, Hanada YU, Misawa H, Horibe K, Chong T, Honda M, Morita Y, Komiyama O. Development of Oropharyngeal Scope Type II with Integrated Tongue Depressor for Examination of the Oropharynx: NTOP2016 Study. Kurume Med J. 2018 Jul 10;64(4):91-95. doi: 10.2739/kurumemedj.MS644003.
Results date posted	2022 Year 12 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow	Evaluation by the attending doctors and display viewers (doctors and medical staffs) 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 (evaluation items A to G, Table 2). Secondary endpoints are to understand patient and family satisfaction (evaluation items H to J, Table 2) and display viewer satisfaction (doctors and other medical staff
Plan to share IPD
IPD sharing Plan description

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

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

Management information
Registered date	2016 Year 12 Month 29 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=R000029318