UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059880 |
|---|---|
| Receipt number | R000068481 |
| Scientific Title | Randomized Controlled Trial Comparing Colorectal Adenoma Detection Rates Using LCI Combined with AI in Colonoscopy with Endocuff Vision vs. Transparent Hood |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/11/25 23:25:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized Controlled Trial Comparing Colorectal Adenoma Detection Rates Using LCI Combined with AI in Colonoscopy with Endocuff Vision vs. Transparent Hood
Acronym
Endocuff vs. Transparent Hood in LCI/AI Colonoscopy for ADR
Scientific Title
Randomized Controlled Trial Comparing Colorectal Adenoma Detection Rates Using LCI Combined with AI in Colonoscopy with Endocuff Vision vs. Transparent Hood
Scientific Title:Acronym
Endocuff vs. Transparent Hood in LCI/AI Colonoscopy for ADR
Region
| Japan |
Condition
Condition
Patients with positive fecal occult blood tests, abdominal symptoms, or follow-up for colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the adenoma detection rate (ADR) when using linked color imaging (LCI) and artificial intelligence (AI) during colonoscopy in patients with positive fecal occult blood tests, abdominal symptoms, or follow-up for colorectal polyps. (AI) during colonoscopy, comparing the adenoma detection rate (ADR) when using Endocuff Vision or a transparent hood attached to the scope tip. This study aims to clarify the usefulness of Endocuff Vision.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adenoma detection rate (ADR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
colonoscopy with an Endocuff Vision
Interventions/Control_2
colonoscopy with a transparent hood
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
1. Patients undergoing colonoscopy after pre-procedural preparation
2. Age: 18 years or older
3. Gender: Not restricted
4. Positive fecal occult blood test, abdominal symptoms, or Surveillance for post-colonoscopic polypectomy
5. Patients who received verbal and written explanations of this study and provided written informed consent
Key exclusion criteria
1. Patients undergoing colonoscopy without prior bowel preparation
2. Patients with intestinal obstruction, stricture, fistula, post-colonic surgery, active inflammatory bowel disease, diverticulitis, active rectal bleeding, or where such conditions cannot be ruled out
3. Patients with alcoholism or drug dependence
4. Patients with severe hormonal disorders such as hyperthyroidism
5. Patients with severe cardiac, hepatic, renal dysfunction, or hematopoietic disorders
6. Patients with severe heart failure or respiratory failure
7. Pregnant women, lactating women, or patients who may be pregnant, or patients who wish to become pregnant during the study period.
8. Patients participating in other studies or clinical trials that may directly or indirectly influence the results of this study.
9. Patients suffering from life-threatening diseases.
10. Patients deemed unsuitable for inclusion by the principal investigator or sub-investigator.iratory failure (NYHA Class III or higher, Hughes-Jones Class IV or higher).
Target sample size
780
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of Gastroenterology
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1829
imaedahi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of Gastroenterology
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1829
Homepage URL
imaedahi@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Saitama Medical University Hospital
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
Tel
0492761667
hirb@saitama-med.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
| 2026 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068481
