UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059447 |
|---|---|
| Receipt number | R000067989 |
| Scientific Title | Additional Right-colon Image-enhanced Surveillance for Enhanced detection in colonoscopy |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/17 19:02:53 |
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Basic information
Public title
Evaluation of short additional observation of the right-sided colon using NBI
Acronym
ARISE study
Scientific Title
Additional Right-colon Image-enhanced Surveillance for Enhanced detection in colonoscopy
Scientific Title:Acronym
ARISE study
Region
| Japan |
Condition
Condition
Colorectal polyps (adenoma and sessile serrated lesions)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate whether a short additional observation of the right-sided colon using narrow band imaging (NBI) during screening colonoscopy improves the detection rate of adenomas and sessile serrated lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Additional detection rate of adenomas and sessile serrated lesions in the right-sided colon.
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
An additional short time observation of the right-sided colon using narrow band imaging following standard white-light imaging.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing screening colonoscopy at the study institution.
Patients aged 18 years or older who receive an explanation of the study and provide written informed consent.
Key exclusion criteria
Patients with a history of right-sided colon resection, inflammatory bowel disease, polyposis syndromes, poor bowel preparation, or incomplete cecal intubation.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Nakachi |
Organization
Kameda Medical Center
Division name
Department of Gastroenterology
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
0470-92-2211
nakachi.kenichiro@kameda.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Miyake |
Organization
Kameda Medical Center
Division name
Department of Gastroenterology
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
0470-92-2211
Homepage URL
t.miyake@med.showa-u.ac.jp
Sponsor or person
Institute
Kameda Medical Center
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
Kameda Medical Center
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
Tel
0470-92-2211
t.miyake@med.showa-u.ac.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
| 2025 | Year | 10 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2025 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067989
