UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052293 |
|---|---|
| Receipt number | R000059698 |
| Scientific Title | Single Center on the Usefulness of Extended Depth of Field (EDOF) in Upper Gastrointestinal Endoscopy/Treatment 2 Group Intervention Prospective Study |
| Date of disclosure of the study information | 2023/09/24 |
| Last modified on | 2025/09/24 22:57:18 |
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Basic information
Public title
Usefulness of Extended Depth of Field (EDOF) in Upper Gastrointestinal Endoscopy/Treatment
Acronym
Usefulness of Depth of Field Expansion in Upper Gastrointestinal Endoscopy / Treatment
Scientific Title
Single Center on the Usefulness of Extended Depth of Field (EDOF) in Upper Gastrointestinal Endoscopy/Treatment 2
Group Intervention Prospective Study
Scientific Title:Acronym
Single Center on the Usefulness of EDOF in Upper Gastrointestinal Endoscopy/Treatment 2
Group Intervention Prospective Study
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
GIF- with EDOF for early-stage gastric cancer (differentiated dominance, cT1a) diagnosed as indicated for endoscopic treatment before surgery
We aimed to evaluate the usefulness of GIF-EZ1500 by randomizing two groups of EZ1500 and GIF-H290Z to mark endoscopic submucosal dissection (ESD), respectively, and comparing the outcomes of endoscopic submucosal dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lesion horizontal stump negative resection rate: In pathological diagnosis after endoscopic treatment, the horizontal stump of the lesion is negative around the perimeter.
The percentage that was. Margin negativity is determined in accordance with the Gastric Cancer Handling Code (15th Edition).
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
GIF-H290Z without EDOF
Interventions/Control_2
GIF-EZ1500 with EDOF
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
1) Early gastric cancer (predominantly differentiated, intramucosal carcinoma) was predicted at the Department of Gastroenterology, Showa University Fujigaoka Hospital, and endoscopy
Patients scheduled for resection
2) Patients who are at least 20 years of age at the time of obtaining consent
3) Patients who have obtained written consent to participate in this study
Key exclusion criteria
1) Patients who are judged to be ineligible by the research physician
2) Patients who are judged by the research physician to be unable to perform endoscopic treatment safely
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Yoshida |
Organization
Showa University Fujigaoka Hospital
Division name
Department of Gastroenterology
Zip code
227-8501
Address
1-30 Fujigaoka,Aobaku,Yokohamashi,Kanagawa,Japan 227-8501
TEL
045-971-1151
smilevc2@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Yoshida |
Organization
Showa University Fujigaoka Hospital
Division name
Department of Gastroenterology
Zip code
227-8501
Address
1-30 Fujigaoka,Aobaku,Yokohamashi,Kanagawa,Japan 227-8501
TEL
045-971-1151
Homepage URL
smilevc2@yahoo.co.jp
Sponsor or person
Institute
Showa University Fujigaoka Hospital
Institute
Department
Personal name
erika yoshida
Funding Source
Organization
Self-procurement
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
Showa University Fujigaoka Hospital Clinical Trial Review Committee
Address
1-30 Fujigaoka,Aobaku,Yokohamashi,Kanagawa,Japan 227-8501
Tel
045-971-1151
smilevc2@yahoo.co.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
| 2023 | Year | 09 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2023 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059698
