UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041436 |
|---|---|
| Receipt number | R000047296 |
| Scientific Title | Evaluation of the usefulness of TXI (Texture and Color Enhancement Imaging) observation in upper gastrointestinal endoscopy |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2020/08/17 08:31:48 |
* 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
Evaluation of the usefulness of TXI (Texture and Color Enhancement Imaging) observation in upper gastrointestinal endoscopy
Acronym
Usefulness of TXI observation in upper gastrointestinal endoscopy
Scientific Title
Evaluation of the usefulness of TXI (Texture and Color Enhancement Imaging) observation in upper gastrointestinal endoscopy
Scientific Title:Acronym
Usefulness of TXI observation in upper gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
Atrophic gastritis
Gastric cancer/Gastric adenoma
Esophageal cancer
Duodenal adenoma/duodenal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of TXI observation for upper gastrointestinal lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Additional effects of TXI observation on upper gastrointestinal lesions on white light observation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with upper gastrointestinal lesions
Key exclusion criteria
1) Minor patients.
2) Patients with comorbidities (e.g., chronic hematological disorders) that make biopsy of the lesion difficult.
3) Patients who cannot discontinue anticoagulants and antiplatelet drugs according to the guidelines for gastrointestinal endoscopy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University School of Medicine, Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
2608670
Address
1-8-1 Inohana
TEL
+81432262083
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Ishikawa |
Organization
Chiba University School of Medicine, Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
2608670
Address
1-8-1 Inohana, Chiba
TEL
0432262083
Homepage URL
tsubasaishikawa19881212@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba 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
Chiba University
Address
1-8-1 Inohana
Tel
0432262083
matsumura@chiba-u.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
| 2020 | Year | 08 | 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
| 2020 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of visibility with white light imaging
Management information
Registered date
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047296
