Tokyo, June 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061989) titled 'Study on the effectiveness of Endoscopic Submucosal Dissection (ESD) using a 3D endoscopy system' 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 - NTT Medical Center Tokyo

Condition: Condition - Esophageal tumor, Gastric tumor, Colorectal tumor Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To clarify the therapeutic outcomes and clinical characteristics of endoscopic submucosal dissection (ESD) using a 3D endoscopy system for esophageal, gastric, and colorectal tumors. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Endoscopic submucosal dissection (ESD) using a 3D endoscopy system

Eligibility: Age-lower limit - 20 years-old = 9 g/dL - Platelet count >= 100,000/mm3 - AST, ALT <= 100 - Serum creatinine <= 2.0 mg/dL 6. Capable of being followed up for 14 days after treatment. 7. Written informed consent has been obtained for participation in the trial. Key exclusion criteria - 1. History of endoscopic treatment for upper or lower gastrointestinal tract lesions within 28 days prior to registration. 2. Scheduled for endoscopic treatment for the upper or lower gastrointestinal tract within 14 days after treatment. 3. Planned to treat multiple lesions simultaneously. 4. Background of active inflammatory bowel disease (ulcerative colitis, Crohn's disease). 5. History of radiation therapy in the planned ESD area. 6. Women who are potentially pregnant, currently pregnant, or breastfeeding. 7. Patients with psychiatric symptoms who are unable to sufficiently understand this study. 8. History of myocardial infarction or unstable angina within the past 3 months. 9. Patients with blood coagulation disorders (regardless of antithrombotic drug use). 10. Patients with active bacterial or fungal infections (having a fever of 38.5 degrees C or higher and complicated by bacterial infection confirmed by imaging or bacteriological examination). 11. Patients with respiratory diseases requiring continuous oxygen administration. 12. Patients with poorly controlled hypertension. 13. Other cases where the attending physician judges participation in this study to be inappropriate. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 17 Day Date of IRB - 2025 Year 12 Month 04 Day Anticipated trial start date - 2026 Year 06 Month 20 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070815

Disclaimer: Curated by HT Syndication.