Using CryoBalloon Therapy for Barrett's Esophagus Treatment

Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)

This study is testing a new treatment called CryoBalloon Therapy to see if it can help people with Barrett's Esophagus who haven't improved with other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (Academic / other)
• Locations: 12 sites (Birmingham, Alabama and 11 other locations)
• Trial ID: NCT03554356 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the CryoBalloon Focal Ablation System (CbFAS) for patients with Barrett's Esophagus who have not responded adequately to previous radiofrequency ablation treatments. Participants will undergo outpatient procedures using high-definition endoscopy to assess and treat their condition. The trial aims to achieve complete eradication of intestinal metaplasia and dysplasia over a treatment period of up to 12 months, with follow-up assessments every three months. The study is multicenter and prospective, involving several prominent medical institutions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of Barrett's Esophagus and persistent dysplasia or intestinal metaplasia after multiple radiofrequency ablation treatments.

Not a fit: Patients who have not undergone prior radiofrequency ablation or those with advanced esophageal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with refractory Barrett's Esophagus, potentially reducing the risk of progression to esophageal cancer.

How similar studies have performed: Other studies have shown promise with similar ablation techniques, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:

   2.1. History of at least 3 RFA treatments, with one or more of the following:
   * 2.1.1. Residual BE Prague \>=C1
   * 2.1.2. Residual BE \>=M1
   * 2.1.3. One or more islands of residual BE \>=1 cm in diameter
   * 2.1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and \< 50% eradication of BE, as judged by estimation of the treating physician.
3. 18 or older years of age at time of consent.
4. Provides written informed consent.
5. Willing to undergo an alternative approved standard of care treatment for their condition.
6. Willing and able to comply with study requirements for follow-up.
7. No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.

Exclusion Criteria:

1. Residual BE Prague length measuring \>C3 or \>M8 after RFA treatment.
2. Dysplasia or IM confined only to the gastric cardia.
3. 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.
4. Symptomatic, untreated esophageal strictures.
5. 5. Any endoscopically visualized abnormalities such as ulcers, masses, or nodules found in the BE 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: 5.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).

   5.2. 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.
6. EMR or ESD \< 6 weeks prior to baseline treatment.
7. Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
8. Active reflux esophagitis grade B or higher in the BE assessed during screening/baseline EGD.
9. Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
10. Uncontrolled coagulopathy.
11. 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.
12. Active fungal esophagitis.
13. Known portal hypertension, visible esophageal varices, or history of esophageal varices.
14. General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
15. Pregnant or planning to become pregnant during period of study participation.
16. Patient refuses or is unable to provide written informed consent.
17. Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Where this trial is running

Birmingham, Alabama and 11 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Georgetown University — Washington, District of Columbia, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
• Northwell Health — Lake Success, New York, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Not_yet_recruiting)
• Columbia University — New York, New York, United States (Recruiting)
• UNC Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
• Geisinger Clinic — Danville, Pennsylvania, United States (Recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
• UTHealth Science Center/Herman Memorial — Houston, Texas, United States (Active_not_recruiting)

Study contacts

• Principal investigator: Nicholas J Shaheeen, MD, MPH — UNC Chapel Hill
• Study coordinator: Lindsay Cortright, MA

Conditions Barrett Esophagus; Intestinal Metaplasia; Esophageal Dysplasia