UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061928 |
|---|---|
| Receipt number | R000070861 |
| Scientific Title | Evaluation of procedural efficiency and bleeding control during colorectal endoscopic submucosal dissection using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex: a prospective feasibility study |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/16 14:55:48 |
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Basic information
Public title
Evaluation of procedural efficiency and bleeding control during colorectal endoscopic submucosal dissection using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex: a prospective feasibility study
Acronym
FAC-HYBRID Colorectal Study
Scientific Title
Evaluation of procedural efficiency and bleeding control during colorectal endoscopic submucosal dissection using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex: a prospective feasibility study
Scientific Title:Acronym
FAC-HYBRID Colorectal Study
Region
| Japan |
Condition
Condition
Colorectal adenoma, early colorectal cancer, or lesions suspected of early colorectal cancer indicated for endoscopic submucosal dissection (ESD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively evaluates the procedural efficiency, hemostatic efficacy, and safety of submucosal dissection (ESD) using Flow-Assisted Coagulation (FAC) and the HYBRIDknifeflex in a water-immersed setting.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Resection time
Key secondary outcomes
* Bleeding duration
* Complete en bloc resection rate
* Total procedure time
* Cumulative bleeding time
* Number of FAC procedures
* FAC-only hemostasis success rate
* Number of hemostatic forceps uses
* Number of device exchanges to hemostatic forceps
* Dissection speed
* CO2 usage time
* Saline consumption
* Safety outcomes
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
Colorectal endoscopic submucosal dissection performed using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex under a gas-free immersion system
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 who provide written informed consent.
2. Patients aged 20 to 100 years.
3. Patients with colorectal adenoma, early colorectal cancer, or lesions suspected of early colorectal cancer that are indicated for endoscopic submucosal dissection (ESD).
4. Patients scheduled to undergo inpatient colorectal ESD.
Key exclusion criteria
1. Patients for whom surgical resection is considered more appropriate.
2. Patients with severe coagulation disorders.
3. Pregnant women or women who may be pregnant.
4. Patients with poor general condition that makes endoscopic treatment unsafe.
5. Patients judged unsuitable for study participation by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatsuma |
| Middle name | |
| Last name | Nomura |
Organization
Suzuka General Hospital
Division name
Gastroenterology
Zip code
5138630
Address
Department of Gastroenterology, Suzuka General Hospital, 1275-53, Yamanohana, Yasuduka, suzuka, Mie
TEL
8159-382-1311
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
5138630
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
Funding Source
Organization
None
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
Institutional Review Board Office, Suzuka Central General Hospital
Address
Suzuka General Hospital, 1275-53, Yamanohana, Yasuzuka, suzuka, Mie, Japan
Tel
+81-5-9382-1311
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
Institutions
Institutions
鈴鹿中央総合病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 16 | 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
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | 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 | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070861
