RecruitingNCT06476678

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection

Sponsor

Baylor College of Medicine

Enrollment

50 participants

Start Date

Oct 15, 2024

Study Type

OBSERVATIONAL

Conditions

Esophageal Neoplasm Endoscopic Submucosal Dissection Esophageal Polyp Bipolar Electrocautery

Summary

Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of device for removing precancerous lesions in the esophagus (the tube connecting your throat to your stomach) using radiofrequency energy — a controlled heat that destroys abnormal tissue from the inside. **You may be eligible if...** - You are over 18 and can give informed consent - You have a mucosal (surface-level) polyp or growth at or near the gastroesophageal junction (where the esophagus meets the stomach) - You have not had previous endoscopic treatment for this lesion - Your lesion meets certain size and location requirements **You may NOT be eligible if...** - Your lesion has grown into deeper tissue layers - You have had prior endoscopic removal attempts on the same lesion - You have conditions making endoscopy unsafe Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpeedboat™ Ultraslim

Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

Locations(1)

Baylor College of Medicine

Houston, Texas, United States

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NCT06476678

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