UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025472
Receipt number 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 2022/12/13 11:20:19

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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 or person

Institute

National Hospital Organization, Nagoya Medical Center

Institute

Department

Personal name



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

Value
https://center6.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