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Evaluation of procedural efficiency and bleeding control during colorectal endoscopic submucosal dissection using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex: a prospective feasibility study

Evaluation of procedural efficiency and bleeding control during colorectal endoscopic submucosal dissection using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex: a prospective feasibility study - FAC-HYBRID Colorectal Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061928
Enrollment
30
Registered
2026-06-16
Start date
2026-06-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal adenoma, early colorectal cancer, or lesions suspected of early colorectal cancer indicated for endoscopic submucosal dissection (ESD)

Interventions

Colorectal endoscopic submucosal dissection performed using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex under a gas-free immersion system

Sponsors

Suzuka General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
* Dissection speed

Secondary

MeasureTime frame
* 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 * Resection time * CO2 usage time * Saline consumption * Safety outcomes

Countries

Japan

Contacts

Public ContactTatsuma Nomura

Suzuka General Hospital Department of Gastroenterology

m06076tn@icloud.com0593821311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026