Study to Test a New Bipolar Radiofrequency Knife for Removing Esophageal Precancerous Lesions Using Endoscopic Submucosal Dissection

What this Trial Is About

Researchers are investigating a new device called the Bipolar Radiofrequency Ablation RFA knife for removing esophageal lesions or polyps using a technique called endoscopic submucosal dissection ESD. This study aims to evaluate the effectiveness, safety, and feasibility of this novel bipolar device compared to traditional monopolar knives, which can cause complications such as post coagulation syndrome and esophageal strictures. The trial is sponsored by Baylor College of Medicine and involves centers experienced in ESD. The procedure involves marking the lesion, injecting a lifting agent beneath it, making circumferential cuts, and dissecting the lesion using the novel Bipolar RFA knife. This device uses a low voltage bipolar current that allows precise cutting and coagulation with less thermal damage to surrounding tissues. It also includes an integrated injection needle to support efficient dissection. Patients eligible for the study will undergo lesion removal using this device during their endoscopy. Participants will be monitored for technical success on the procedure day and followed up to assess procedure speed, instrument use, muscle injury, post-electrocautery syndrome, pain levels, esophageal strictures, scar formation, and cost of dissection. Assessments will be made during and after the procedure, with follow-ups extending up to six months. The study duration for each participant depends on their individual follow-up schedule and outcomes.

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions