UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034987
Receipt number R000039900
Scientific Title Computer-aided detection for colonoscopy based on artificial intelligence
Date of disclosure of the study information 2018/12/01
Last modified on 2022/11/29 08:53:54

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Basic information

Public title

Computer-aided detection for colonoscopy based on artificial intelligence

Acronym

Evaluation for CADe software

Scientific Title

Computer-aided detection for colonoscopy based on artificial intelligence

Scientific Title:Acronym

Evaluation for CADe software

Region

Japan


Condition

Condition

Colorectal lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of CADe software(EB-00) using colonoscopy video database.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The sensitivity of CADe(EB-00) for colorectal lesions.

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Pts who were performed colonoscopy in Showa University Northern Yokohama Hospital.
2)Over 20 years old.
3)Pts with informed consent.

Key exclusion criteria

1) Inflammatory bowel disease
2) Polyposis

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Misawa

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama

TEL

045-949-7265

Email

mmisawa@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Misawa

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama

TEL

045-949-7265

Homepage URL


Email

mmisawa@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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 12 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

2018 Year 07 Month 01 Day

Date of IRB

2018 Year 07 Month 01 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2018 Year 09 Month 01 Day

Date of closure to data entry

2018 Year 10 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

We evaluated the performance of CADe software using colonoscopy video database which were taken at Showa University Northern Yokohama Hospital from August 2018 to October 2018.


Management information

Registered date

2018 Year 11 Month 24 Day

Last modified on

2022 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039900


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name