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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044031
Receipt No. R000050279
Scientific Title Evaluation of the impact of CAD EYE on the quality of colonoscopy and the learning curve of gastroenterology fellows
Date of disclosure of the study information 2021/04/26
Last modified on 2021/04/25

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Basic information
Public title Evaluation of the impact of CAD EYE on the quality of colonoscopy and the learning curve of gastroenterology fellows
Acronym cad eye b study
Scientific Title Evaluation of the impact of CAD EYE on the quality of colonoscopy and the learning curve of gastroenterology fellows
Scientific Title:Acronym cad eye b study
Region
Japan

Condition
Condition Patients who were referred and scheduled for total colonoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To conduct a randomized clinical trial of endoscopic observation using CAD EYE and normal endoscopic observation (WLI) to compare the adenoma detection and polyp miss rates.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adenoma Detection Rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Group A: Colonoscopy observation with CAD EYE
Interventions/Control_2 Group B: Colonoscopy observation with WLI
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
18 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1 patients between 18 and 79 years of age (at the time of signing the consent form) undergoing lower gastrointestinal endoscopy.
2 patients who understand the contents of the consent document and can sign the consent form of their own free will (in the case of minors, their guardians).
3 patients who are required to undergo lower gastrointestinal endoscopy (patients who meet any of the following conditions)
patients with positive fecal occult blood
patients who have been previously diagnosed or treated for colorectal adenoma or colorectal cancer (not applicable for those who have undergone colorectal resection)
those with digestive symptoms such as abdominal pain, diarrhea, constipation, etc.
those who need to be screened for gastrointestinal cancer.
those who have a family history of colorectal cancer or colorectal adenoma.
those who have a family history of colorectal cancer or colorectal adenoma
other patients who are judged to need lower gastrointestinal endoscopy by the physician in charge
Key exclusion criteria patients who have undergone bowel resection.
patients with a history of inflammatory bowel disease.
patients with a history of familial adenomatous polyposis
patients with a history of hereditary non-polyposis colorectal cancer
patients with a known history of severe intestinal adhesions
patients who are judged by their physician to be unable to participate in the study
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Yamaguchi
Organization Ureshino Medical Center
Division name Gastroenterology
Zip code 8430393
Address Shimojyukukou 4279-3, Ureshino city
TEL 0954431120
Email daisukehawks@gmail.com

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Yamaguchi
Organization Ureshino Medical Center
Division name Gastroenterology
Zip code 8430393
Address Shimojyukukou 4279-3, Ureshino city
TEL 0954431120
Homepage URL
Email daisukehawks@gmail.com

Sponsor
Institute Ureshino Medical Center
Institute
Department

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 Institutional Review Board of Ureshino Medical Center
Address Shimojyukukou 4279-3, Ureshino city
Tel 0954431120
Email honjo.yoko.vd@mail.hosp.go.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
2021 Year 04 Month 26 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 10 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 25 Day
Last modified on
2021 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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