Study Details

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NO FEAR-BE: Barrett's Esophagus Ablation Study

This research study is looking at a newer treatment option for Barrett's Esophagus (BE) which uses Nitrous Oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA cleared device, is another, newer way of treating Barrett's Esophagus. To evaluate the newer treatment, we are enrolling patients who are not responding as well as expected to RFA. Patients with at least 2 or more previous RFA treatments who still have BE may be eligible.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

You will receive cryotherapy about every 2-3 months for up to one year (12 months). - Prior to each cryotherapy visit, you will meet with a member of the study team and complete questionnaires. - After each cryotherapy visit, you will complete a questionnaire at home and receive phone calls 1, 7, and 30 days to check on your health. After completing cryotherapy, the study team will follow you up to one year (12 months) to collect information about your health. Your doctor will ask you to come in at least once every 6 months, but may ask you to come back more often to check on your health. Throughout the research study, all treatments and procedures will be a part of your normal clinical care and the study team will collect information about your health from your medical record.

In-person visits:
At least 4

Phone or online visits:
At least 3

Total length of participation:
1.5-2 years

Looking for Specific Volunteers

Able to participate:

History of Barrett's Esophagus (BE).
At least 2 prior treatments with radiofrequency ablation (RFA) and still have some BE.
3. You are willing to undergo a different, FDA-approved treatment for BE.
4. You have never received esophageal treatment with balloon or spray cryotherapy.

Not eligible if:

1. You have a narrowing of your esophagus, also called an esophageal stricture, that is too narrow for the endoscope.
2. You've had prior esophageal surgery (other than surgery for reflux).
3. You have problems with your esophagus because of liver disease, including visibly enlarged veins in your esophagus (known as esophageal varices).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

GI Clinic
NC Memorial Hospital
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Nicholas Shaheen
Center for Gastrointestinal Biology and Disease

Study Type

Clinical or Medical
Observational

Study Topics

Stomach, Digestion and Gut Health

IRB Number

18-0388

ClinicalTrials.gov

NCT03554356