Comparing Two Electrosurgical Techniques for Endoscopic Muscle Cutting in Esophageal Motility Disorders A Randomized Phase 3 Trial

What this Trial Is About

Researchers are evaluating two electrosurgical modes used in a procedure called Peroral Endoscopic Esophageal Myotomy POEM, which treats esophageal motility disorders such as achalasia. POEM involves creating a tunnel under the esophageal lining to cut muscle and improve swallowing. This phase 3 randomized trial compares the safety and effectiveness of Spray coagulation mode and Precisect mode during the submucosal dissection step of POEM. Participants will undergo the POEM procedure where, after an initial incision, the submucosal dissection is performed using either Spray coag mode or Precisect mode with an ERBE VIO3 generator and a Hybrid knife, supported by ERBEJET for injection. The Spray coag mode uses effect settings of 3 to 3.5, while Precisect mode uses effects of 4.5 to 5. Both methods aim to safely and efficiently dissect tissue down to 2 cm below the cardia. The study includes a double-blind design with random assignment to either mode. During the procedure, researchers will measure the speed of submucosal dissection as the primary outcome. Secondary outcomes include bleeding during the procedure, any significant bleeding events, other adverse events, total procedure duration, and the duration of endoscopic submucosal tunneling. Participants will be monitored closely for safety and effectiveness during the procedure. The study aims to provide evidence on which electrosurgical mode offers better performance and safety in POEM treatment. The trial is expected to complete by August 2025.

Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy