UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025848
Receipt number R000029725
Scientific Title Patient's acceptance of unsedated transnasal endoscopy versus conventional endoscopy: a prospective raodomized comparative study
Date of disclosure of the study information 2017/02/01
Last modified on 2020/06/02 13:11:17

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Basic information

Public title

Patient's acceptance of unsedated transnasal endoscopy versus conventional endoscopy: a prospective raodomized comparative study

Acronym

Patient's acceptance of unsedated transnasal endoscopy versus conventional endoscopy

Scientific Title

Patient's acceptance of unsedated transnasal endoscopy versus conventional endoscopy: a prospective raodomized comparative study

Scientific Title:Acronym

Patient's acceptance of unsedated transnasal endoscopy versus conventional endoscopy

Region

Japan


Condition

Condition

upper gastrointestinal disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the patient's acceptance of nasal endoscopy and conventinoal endoscopy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS scale of patient's acceptance after endoscopic examination: conventinal endoscopy using EG-L600WR7 vs transnasal endoscopy using EG-L580NW7, transnasal endoscopy using EG-L580NW7 vs GIF-H290N

Key secondary outcomes

The autonomic nervous responses were determined from heart-rate variations: HF power/LF power and Log HF power during examination.
Systolic blood pressure and pulse rate.
Procedure time during and after examinatioGagging: conventinal endoscopy using EG-L600WR7 vs transnasal endoscopy using EG-L580NW7, transnasal endoscopy using EG-L580NW7 vs GIF-H290N


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Conventional endoscopy using EG-L600WR7

Interventions/Control_2

Nasal endoscopy using EG-L580NW7

Interventions/Control_3

Nasal endoscopy using GIF-H290N

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases evaluated by unsadated upper gastrointestinal endoscopy

Key exclusion criteria

Cases with severe complications are excluded.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Hattori

Organization

Medical corporation Yamashita Hospital

Division name

Gastroenterology

Zip code

4918531

Address

1-3-5, Nakamachi, Ichinomiya

TEL

0586-45-4511

Email

m.hattori@yamashita.or.jp


Public contact

Name of contact person

1st name Ippei
Middle name
Last name Matsuzaki

Organization

Medical corporation Yamashita Hospital

Division name

Gastroenterology

Zip code

4918531

Address

1-3-5, Nakamachi, Ichinomiya

TEL

0586-45-4511

Homepage URL


Email

imatsu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Medical corporation Yamashita Hospital

Institute

Department

Personal name



Funding Source

Organization

Fujifilm Co., Tokyo, Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical corporation Yamashita Hospital

Address

1-3-5, Nakamachi, Ichinomiya

Tel

0586-45-4511

Email

y.okudaira@yamashita.or.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

2017 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2017 Year 01 Month 26 Day

Date of IRB

2017 Year 01 Month 26 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2020 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 26 Day

Last modified on

2020 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name