Using a new bipolar knife for removing esophageal lesions
Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06476678 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with precancerous mucosal-based polyps located at or proximal to the gastroesophageal junction.
Not a fit: Patients with lesions extending past the gastroesophageal junction or those with significant coagulopathy may not benefit from this study.
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 performed: Previous studies have shown success with bipolar electrocautery in other endoscopic procedures, suggesting potential for this novel approach.
Eligibility criteria
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 this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Salmaan A Jawaid, MD
- Email: Salmaan.Jawaid@bcm.edu
- Phone: 7137980950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.