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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient is \>18 years of age - Patient can provide willing to sign a consent form - Patient is referred for resection of precancerous lesions meeting the following criteria: - Mucosal based polyp - Located gastroesophageal junction (GEJ) or proximal to GEJ - No previous endoscopic resection attempted (EMR or ESD) Who Should NOT Join This Trial: - Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000 - Lesions extending past GEJ - Subepithelial lesions Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient is \>18 years of age * Patient can provide informed consent * Patient is referred for resection of precancerous lesions meeting the following criteria: * Mucosal based polyp * Located gastroesophageal junction (GEJ) or proximal to GEJ * No previous endoscopic resection attempted (EMR or ESD) Exclusion Criteria: * Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000 * Lesions extending past GEJ * Subepithelial lesions

Treatments Being Tested

DEVICE

Speedboat™ Ultraslim

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

Locations (1)

Baylor College of Medicine
Houston, Texas, United States