Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor College of Medicine

About this trial

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 criteria

Qualifiers

Patient is >18 years of age

Patient can provide informed consent

Mucosal based polyp

Located gastroesophageal junction (GEJ) or proximal to GEJ

Disqualifiers

Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000

Lesions extending past GEJ

Subepithelial lesions

Trial design

Treatments tested in this trial

  • Speedboat™ Ultraslim

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Baylor College of Medicine

Lead sponsor

Creo Medical Limited

Collaborator