Evaluating Safety and Effectiveness of the SpydrBlade Flex Device for Per-Oral Endoscopic Myotomy in Adults with Achalasia

What this Trial Is About

Achalasia is a disorder where the esophagus has trouble moving food down because the lower esophageal sphincter LES does not relax properly. Patients often experience worsening swallowing difficulties, along with symptoms like nighttime cough, heartburn, weight loss, and food regurgitation. Diagnosis usually involves tests like esophageal imaging, endoscopy, and manometry, with the Eckardt Symptom Score ESS used to judge the severity and treatment effect. This trial aims to assess a new device designed to improve a minimally invasive treatment called per-oral endoscopic myotomy POEM in patients with achalasia. The study evaluates the safety and effectiveness of a novel SpydrBlade Flex device, which uses radiofrequency and microwave ablation technology for the POEM procedure. This device may be used with either the anterior or posterior POEM approach, depending on the patients condition and the doctors preference. The treatment involves creating a tunnel in the esophagus lining and cutting muscle to reduce LES pressure, helping food pass into the stomach more easily. Participants will undergo the POEM procedure using this new device. Researchers will monitor several outcomes, including the technical success of the procedure within one day and clinical symptom improvement after 30 days. Safety will be tracked by noting any complications during and after the operation. Additional assessments of reflux symptoms, esophageal function, and quality of life will be done up to six months post-procedure. The total study duration allows for follow-up to ensure safety and measure longer-term effects.

Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM