NCT06476678Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 21 Jun 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06476678
What you commit to
- Study type: Observational
- Planned participants: 50
- From 15 Oct 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000
Other
- Lesions extending past GEJ
- Subepithelial lesions
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.