Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Description

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.

Conditions

Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electrocautery

Study Overview

Study Details

Study overview

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.

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

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Condition
Esophageal Neoplasm
Intervention / Treatment

-

Contacts and Locations

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

Study Record Dates

2025-12-31