UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035187 |
|---|---|
| Receipt number | 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 14:13:31 |
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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
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
n.akizue@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039883
