Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Recruiting · NCT06476678 · Observational (researchers observe without assigning treatment) · Lead sponsor: Baylor College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
1 location listed across 1 US state.
- Baylor College of Medicine - Houston, Texas, United States