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Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Baylor College of Medicine · Participants: 50 · Started: Oct 15, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06476678

Locations in the U.S.

TexasBaylor College of Medicine, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.