UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026111 |
|---|---|
| Receipt number | R000029865 |
| Scientific Title | Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial. |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2022/09/29 08:38:34 |
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Basic information
Public title
Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Acronym
Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Scientific Title
Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Scientific Title:Acronym
Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Region
| Japan |
Condition
Condition
The patients who underwent upper gastrointestinal endoscopy.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the novel image enhanced endoscopy (IEE) observation compared with the conventional white light (WLI) observation in detecting neoplastic stomach lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Superiority in detectability of neoplastic stomach lesions using a novel IEE as compared to WLI.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Image enhanced endoscopy (IEE)
Interventions/Control_2
White ligth (Xenon)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- A person who undergo UGD endoscopy for the screening of the multi-focal cancer (synchronous / metachronous)
- age ranged from 20 years to 80 years
Key exclusion criteria
- A person who is untolerable for a biopsy
- A person who is unsuitable to undergo the procedure
- A person who did not agree to participate.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Ito |
Organization
Kanazawa Medical University
Division name
Gastroenterological Endoscopy
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
itotohru@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Ito |
Organization
Kanazawa Medical University
Division name
Gastroenterological Endoscopy
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Homepage URL
itotohru@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa 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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 13 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029865
