UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033991
Receipt number R000038760
Scientific Title Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy
Date of disclosure of the study information 2018/09/02
Last modified on 2020/03/04 18:18:47

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Basic information

Public title

Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy

Acronym

Verification of usefulness and safety of 3-dimensional flexible endoscopy in endoscopic therapy

Scientific Title

Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy

Scientific Title:Acronym

Verification of usefulness and safety of 3-dimensional flexible endoscopy in endoscopic therapy

Region

Japan


Condition

Condition

early gastric cancer, gastric adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic submucosal dissection for early gastric cancers and gastric adenomas.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. diagnosed degree of perception of lesion
2. correct diagnosis rate of lesion range

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Endoscopic diagnosis and endoscopic therapy with 2D vision or 3D vision

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients who have been diagnosed with early gastric cancers or gastric adenomas
2.Patients who understood study, and provided written consent based on their own will

Key exclusion criteria

1.Patients in pregnancy or lactation
2.Patients who ever participated other clinical trials in latest 3 months
3.Patients decided to be contraindicated by the person in charge

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazutoshi Higuchi

Organization

Nippon Medical School

Division name

Department of Gastroenterology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

k-higuchi@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutoshi Higuchi

Organization

Nippon Medical School

Division name

Department of Gastroenterology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

k-higuchi@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 02 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

2018 Year 06 Month 22 Day

Date of IRB

2018 Year 06 Month 08 Day

Anticipated trial start date

2018 Year 09 Month 03 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 02 Day

Last modified on

2020 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=R000038760


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name