UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044640
Receipt number R000050540
Scientific Title Visibility evaluation study of upper gastrointestinal endoscopy for esophageal and gastric cancer using the GIF-1200N ultra-fine diameter general-purpose upper gastrointestinal videoscope
Date of disclosure of the study information 2021/06/30
Last modified on 2024/03/04 17:09:53

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Basic information

Public title

A single-center prospective observational study to investigate the visibility of endoscopic findings of esophageal and gastric cancers using the GIF-1200N ultra-fine diameter general-purpose upper gastrointestinal videoscope

Acronym

Visibility study of upper gastrointestinal endoscopy for esophageal and gastric cancer

Scientific Title

Visibility evaluation study of upper gastrointestinal endoscopy for esophageal and gastric cancer using the GIF-1200N ultra-fine diameter general-purpose upper gastrointestinal videoscope

Scientific Title:Acronym

Visibility study of upper gastrointestinal endoscopy for esophageal and gastric cancer

Region

Japan


Condition

Condition

Esophageal cancer, Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the visibility of endoscopic findings of esophageal and gastric cancer using images obtained with the GIF-1200N, GIF-EZ1500, and GIF-XZ1200 general-purpose videoscopes for the upper gastrointestinal tract.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Evaluation of the equivalence between the visibility of endoscopic findings of GIF-1200 and those of GIF-EZ1500 and GIF-XZ1200

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

At the time of upper endoscopy, endoscopic observation of the lesion will be performed using GIF-XZ1200 or GIF-EZ1500. 5 minutes later, endoscopic observation of the lesion will be performed using GIF-1200N. The duration of intervention is 1 day and the number of interventions is 1 time.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who are at least 20 years old at the time of participation in this study.
(2) Patients who are scheduled to undergo endoscopic resection.
(3) Patients who have given written consent to use the GIF-1200N and the GIF-EZ1500 or GIF-XZ1200 for observation immediately before endoscopic resection.

Key exclusion criteria

Patients whose participation in this study is judged inappropriate by the physician in charge.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yasuaki
Middle name
Last name Furue

Organization

Kitasato university School of Medicine

Division name

Gatroenterology

Zip code

252-0374

Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8111

Email

yfurue@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Yasuaki
Middle name
Last name Furue

Organization

Kitasato university School of Medicine

Division name

Gatroenterology

Zip code

252-0374

Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8111

Homepage URL


Email

yfurue@kitasato-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Kitasato university School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology, Kitasato university School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Office, Kitasato University Hospital

Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

Tel

042-778-8273

Email

rinrib@med.kitasato-u.ac.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

北里大学病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 30 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

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 17 Day

Date of IRB

2021 Year 07 Month 20 Day

Anticipated trial start date

2021 Year 08 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

2026 Year 03 Month 31 Day

Date trial data considered complete

2026 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 24 Day

Last modified on

2024 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050540


Research Plan
Registered date File name
2023/01/05 ■1200N消化器内科研究計画書■_Ver2.0_20220224.docx

Research case data specifications
Registered date File name
2023/01/05 記録用紙_食道癌ver2.0.docx

Research case data
Registered date File name