Ensayos clínicos

Inclusion Criteria:

• History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, > T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
• Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:
• History of at least 3 RFA treatments, with one or more of the following:
  • Residual BE Prague ≥ C1*;
  • Residual BE > M1*;
  • One or more islands of residual BE ≥ 1 cm in diameter;
  • Any residual dysplasia in tubular esophagus.
    • History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
• 18 or older years of age at time of consent.

*Any residual BE greater than Prague C3 or greater than Prague M8 will be excluded. 

• Provides written informed consent on the IRB/EC-approved informed consent form.
• Willing to undergo an alternative approved standard of care treatment for their condition.
• Willing and able to comply with study requirements for follow-up.
• No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.

Exclusion Criteria:

• Residual BE Prague length measuring > C3 or > M8 after RFA treatment.
• Dysplasia or IM confined only to the gastric cardia (BE Prague C0M0).
• Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
• Symptomatic, untreated esophageal strictures.
• Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that:
  • Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia);
  • Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, > T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
• EMR or ESD < 6 weeks prior to baseline treatment.
• Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
• Active reflux esophagitis grade B or higher assessed during screening/baseline EGD.
• Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
• Uncontrolled coagulopathy.
• Inability to hold use of anti-coagulation medications or non-aspirin anti- platelet agents (APAs) for the duration recommended per ASGE guidelines for a high risk endoscopy procedure.
• Active fungal esophagitis.
• Known portal hypertension, visible esophageal varices, or history of esophageal varices.
• General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
• Pregnant or planning to become pregnant during period of study participation.
• Patient refuses or is unable to provide written informed consent.
• Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Eligibility last updated 12/1/22. Questions regarding updates should be directed to the study team contact.