Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Launched by BAYLOR COLLEGE OF MEDICINE · Jun 21, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new tool called the Bipolar Radiofrequency Ablation Knife, which is being used to treat certain types of growths in the esophagus, specifically precancerous lesions. The researchers at Baylor College of Medicine want to see how effective, safe, and practical this new device is compared to traditional methods. The study is taking place at two well-respected medical centers, Baylor St Luke's Medical Center and Mayo Scottsdale, both known for their expertise in a procedure called endoscopic submucosal dissection (ESD), which is used to remove abnormal tissue from the digestive tract.

To participate in this trial, you need to be at least 18 years old and able to give your consent. You should be referred for the removal of specific types of growths in the esophagus that haven't been treated before. However, if you have certain health issues, like a high blood clotting risk or specific types of lesions, you may not be eligible. If you join the study, you can expect to receive careful monitoring and support from the medical team as they assess the effectiveness and safety of this new treatment method. Your involvement will help advance knowledge in treating esophageal conditions and could benefit future patients.

Gender

ALL

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