UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060426 |
|---|---|
| Receipt number | R000069122 |
| Scientific Title | Visual Improvement Study using NBI (Narrow Band Imaging) combined with TXI (Texture and Color Enhancement Imaging) |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/21 17:21:13 |
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Basic information
Public title
Retrospective Observational Study Evaluating the Diagnostic Performance of a Novel Endoscopic Mode Combining NBI and TXI for Lesion Identification
Acronym
NBI-TXI study
Scientific Title
Visual Improvement Study using NBI (Narrow Band Imaging) combined with TXI (Texture and Color Enhancement Imaging)
Scientific Title:Acronym
NBI-TXI VISION Study
Region
| Japan |
Condition
Condition
neoplastic or non-neoplastic lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Narrow Band Imaging (NBI), which utilizes short-wavelength light, provides excellent visualization of superficial mucosal microvasculature and structures and is widely used in gastrointestinal endoscopic diagnosis. However, NBI alone has inherent limitations in image brightness and color contrast, and therefore may not always provide sufficient visibility or discrimination of lesions.
In contrast, Texture and Color Enhancement Imaging (TXI) is a novel image enhancement technology that performs luminance correction and color enhancement. When used in combination with conventional NBI, TXI is expected to further improve lesion visibility and discrimination. This combined approach may be particularly useful for lesions that are difficult to detect, such as flat or early-stage lesions.
The aim of this study was to compare lesion visibility and discrimination between NBI alone and NBI combined with TXI using previously stored gastrointestinal endoscopic images. Through this comparison, we sought to clarify the effectiveness of combining TXI with NBI and to contribute to improved diagnostic performance in clinical endoscopic practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective visibility scores (margin clarity and microstructural discriminability)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Neoplastic or non-neoplastic lesions identified during upper and lower gastrointestinal endoscopic examinations performed at our institution between August and September 2025
Key exclusion criteria
Unclear image quality, difficulty in defining the region of interest (ROI), incomplete clinical records, or withdrawal of consent (opt-out refusal)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | NANOKA |
| Middle name | |
| Last name | CHIYA |
Organization
Saitama medical University International Medical Center
Division name
Department of gastroenterology
Zip code
3501298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
0429844111
nnk1011row@yahoo.co.jp
Public contact
Name of contact person
| 1st name | NANOKA |
| Middle name | |
| Last name | CHIYA |
Organization
Saitama medical University International Medical Center
Division name
Department of gastroenterology
Zip code
3501298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
0429844111
Homepage URL
nnk1011row@yahoo.co.jp
Sponsor or person
Institute
Saitama medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama medical University International Medical Center
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
Saitama medical University International Medical Center
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
0429844111
imc_irb@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 | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study using archived gastrointestinal endoscopic images.
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069122
