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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025472
Receipt No. R000029318
Scientific Title Clinical study for Pharyngeal Video Scope Type-2 National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2016
Date of disclosure of the study information 2016/12/29
Last modified on 2018/07/02

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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
Publication of results Partially published

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
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
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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