Ensayos clínicos

This study has been terminated

Inclusion Criteria:

• English speaking males or females aged 18 to 85 who are candidates for sedated endoscopy with treatment of BE.
• At least 3 centimeters segment length of Barrett's Esophagus (BE) with or without circumferential involvement (i.e. CxM3) and with high grade or low grade dysplasia based on pathology results from 4 quadrant biopsies taken every 1-2 centimeter throughout the BE. All readings of dysplasia will be confirmed by an expert pathologist.
• Willing to undergo spray cryotherapy and judged by patient's physician as an appropriate candidate for this therapy.
• Able to read, comprehend, and complete the informed consent form

Exclusion Criteria:

• Bleeding disorder or other contraindication of spray cryotherapy.
• History of partial or complete esophagectomy.
• Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
• Pregnant women
• Contraindication to endoscopic spray cryotherapy as outlined in the directions for use for the device
• Previous endoscopic ablation treatment (such as radiofrequency ablation (RFA) or photodynamic therapy (PDT)).
• Previous chest external beam radiation therapy.
• Previous wide-area endoscopic resection or submucosal dissection. Previous focal mucosal resection is permitted (maximum 2 previous EMR's of 2cm or less removed representing less than 25% of the circumference of the esophagus removed).