Tokyo, June 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061973) titled 'Prospective feasibility study of HYBRIDknifeflex-assisted gastric ESD using Gas-free Immersion and Flow-Assisted Coagulation' on June 20.

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 - Gastric adenoma and early gastric cancer indicated for endoscopic submucosal dissection (ESD) Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 20 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 Size - 50

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070913

Disclaimer: Curated by HT Syndication.