Using a new bipolar knife for removing esophageal lesions
Official title: Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
Run by Baylor College of Medicine · NCT06476678 · Data updated 2026-11-12
This study is testing a new type of tool for safely removing esophageal growths in patients with precancerous lesions to see if it works better than older methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | October 15, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06476678 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with precancerous mucosal-based polyps located at or proximal to the gastroesophageal junction.
✕Probably not a fit
Patients with lesions extending past the gastroesophageal junction or those with significant coagulopathy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy, safety, and feasibility of a novel bipolar-current endoscopic submucosal dissection (ESD) device for the removal of esophageal lesions. Conducted at Baylor St Luke's Medical Center and Mayo Scottsdale, the research aims to improve upon traditional monopolar knives that can cause complications such as post coagulation syndrome and esophageal strictures. The ESD technique is minimally invasive, allowing for the removal of high-risk esophageal polyps without the need for more invasive surgical procedures. The study will prospectively assess outcomes in patients referred for resection of precancerous lesions.
Why it matters
Potential benefit: If successful, this approach could reduce complications and improve recovery for patients undergoing esophageal lesion removal.
How similar studies have gone: Previous studies have shown success with bipolar electrocautery in other endoscopic procedures, suggesting potential for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Baylor College of Medicine
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Salmaan A Jawaid, MD
- Email: Salmaan.Jawaid@bcm.edu
- Phone: 7137980950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.