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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035187
Receipt No. R000039883
Scientific Title Randomized controlled trial to examine the ability of colorectal lesion detection using 3D monitor system
Date of disclosure of the study information 2018/12/10
Last modified on 2018/12/09

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Basic information
Public title Randomized controlled trial to examine the ability of colorectal lesion detection using 3D monitor system
Acronym Examination for the ability for colorectal lesion detection using 3D monitor system
Scientific Title Randomized controlled trial to examine the ability of colorectal lesion detection using 3D monitor system
Scientific Title:Acronym Examination for the ability for colorectal lesion detection using 3D monitor system
Region
Japan

Condition
Condition colon polyp
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim was to evaluate whether adenoma detection rate (ADR), which is considered to be the most important quality indicator of colonoscopy, is improved by using 3D monitor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes adenoma detection rate
Key secondary outcomes polyp detection rate
polyp per colonoscopy
colonoscope insertion time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 observation by white light
Interventions/Control_2 observation by 3D colonoscopy
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) Screening including fecal occult blood test positive
2) Surveillance after endoscopic resection of colon neoplastic lesion
3) Scrutiny of abdominal cases
Key exclusion criteria 1) Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.)
2) Patients with familial adenomatous polyposis
3) Patients with history of colon resection
4) Patients who are strongly suspected of having tumor before examination (such as when suspected by other imaging tests or when lesions have not been excised at previous colonoscopy)
5) Patients who have difficulty in lesion biopsy (such as chronic blood diseases)
6) Patients who can not discontinue anticoagulant or antiplatelet drug according to endoscopic clinical practice guidelines
Target sample size 362

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address Chiba
TEL 0432262086
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Akizue
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 0432262086
Homepage URL
Email n.akizue@gmail.com

Sponsor
Institute Department of Gastroenterology, Chiba University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Chiba University Hospital
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 千葉大学病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 10 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 Terminated
Date of protocol fixation
2018 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 09 Day
Last modified on
2018 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039883

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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