Tokyo, June 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061928) titled 'Evaluation of procedural efficiency and bleeding control during colorectal endoscopic submucosal dissection using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex: a prospective feasibility study' on June 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Suzuka General Hospital
Condition:
Condition - Colorectal adenoma, early colorectal cancer, or lesions suspected of early colorectal cancer indicated for endoscopic submucosal dissection (ESD)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Colorectal endoscopic submucosal dissection performed using Flow-Assisted Coagulation (FAC) and HYBRIDknifeflex under a gas-free immersion system
Eligibility:
Age-lower limit - 20
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070861
Disclaimer: Curated by HT Syndication.
