Tokyo, Nov. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059777) titled 'Feasibility of Endoscopic Submucosal Dissection Using a Novel Anchor Ring-Shaped Thread Counter-Traction Method' on Nov. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Ehime University

Condition: Condition - Early malignant tumors of the upper gastrointestinal tract (esophagus, stomach, and duodenum) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to clarify the applicability of a novel anchor ring-shaped thread counter-traction method as an adjunctive traction technique for Endoscopic Submucosal Dissection. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Endoscopic Submucosal Dissection assisted by a novel anchor ring-shaped thread counter-traction method. The procedure involves placing an anchoring ring-thread clip on the proximal side of the lesion, advancing a ring-thread clip toward the lesion to provide traction, and performing submucosal dissection under improved visualization until completion of resection.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with early malignant tumors of the upper gastrointestinal tract (esophagus, stomach, or duodenum) scheduled to undergo Endoscopic Submucosal Dissection in which the novel anchor ring-shaped thread counter-traction method will be applied. 2. Patients who provide written informed consent. 3. No restrictions on age or sex. Key exclusion criteria - 1. Patients deemed to be at high risk for endoscopic treatment (Endoscopic Submucosal Dissection) due to poor general condition or other clinical factors. 2. Patients who do not provide informed consent for participation in this study. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 06 Day Date of IRB - 2025 Year 10 Month 27 Day Anticipated trial start date - 2025 Year 11 Month 15 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068352

Disclaimer: Curated by HT Syndication.