Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Recruiting now

Conditions studied: Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electrocautery

In brief

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.

Key facts

Study ID

NCT06476678

Run by

Baylor College of Medicine

People needed

50

Starts

2024-10-15

Expected to finish

2027-12-31

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000
• Lesions extending past GEJ
• Subepithelial lesions

Where it is running

• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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