Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorBaylor College of Medicine
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedOctober 15, 2024
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT06476678 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.