UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061973 |
|---|---|
| Receipt number | R000070913 |
| Scientific Title | Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation |
| Date of disclosure of the study information | 2026/06/20 |
| Last modified on | 2026/06/19 12:02:49 |
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Basic information
Public title
Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation
Acronym
Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation
Scientific Title
Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation
Scientific Title:Acronym
Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation
Region
| Japan |
Condition
Condition
Gastric adenoma and early gastric cancer indicated for endoscopic submucosal dissection (ESD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively evaluate the feasibility, safety, and procedural efficiency of gastric endoscopic submucosal dissection (ESD) using HYBRIDknifeflex in combination with the Gas-free Immersion (GFI) system and Flow-Assisted Coagulation (FAC). Particular emphasis will be placed on dissection speed, procedure time, injection time, hemostasis time, and bleeding-related outcomes to determine whether this strategy can improve the efficiency of gastric ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dissection speed (mm2min)
Key secondary outcomes
1. Procedure time
2. Resection time
3. Injection time
4. Hemostasis time
5. Number of intraoperative bleeding events
6. Total bleeding duration
7. Volume of injection solution
8. Number of hemostatic forceps uses
9. En bloc resection rate
10. R0 resection rate
11. Intraoperative perforation
12. Delayed bleeding
13. PECS
14. Aspiration pneumonia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Gastric ESD will be performed using HYBRIDknifeflex under the Gas-free Immersion (GFI) system. Flow-Assisted Coagulation (FAC) will be used for prophylactic coagulation and hemostasis when appropriate. The study prospectively evaluates the feasibility, safety, and procedural efficiency of this strategy.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 to 100 years.
2. Patients with gastric adenoma, early gastric cancer, or gastric epithelial neoplasms suspected of early gastric cancer.
3. Patients judged to be indicated for gastric ESD according to clinical practice and relevant guidelines.
4. Patients scheduled to undergo gastric ESD during hospitalization.
5. Patients who provide written informed consent.
Key exclusion criteria
1. Patients for whom surgical treatment is considered more appropriate.
2. Patients with severe comorbidities precluding safe endoscopic treatment or sedation.
3. Patients with severe coagulation disorders or other conditions that make ESD unsafe.
4. Pregnant women or patients suspected of being pregnant.
5. Patients judged inappropriate for participation by the investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Department of Gastroenterology
Zip code
510-0235
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie
TEL
09064948705
m06076tn@icloud.com
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Department of Gastroenterology
Zip code
510-0235
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie
TEL
0593821311
Homepage URL
m06076tn@icloud.com
Sponsor or person
Institute
Suzuka General Hospital
Institute
Department
Personal name
Tatsuma Nomura
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board Office, Suzuka Central General Hospital
Address
Department of Gastroenterology, Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie,
Tel
0593821311
m06076tn@icloud.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
None Selected
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 20 | 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
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 22 | 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
| 2026 | Year | 06 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070913
