CryoBalloon for Barrett Esophagus
This study is evaluating whether cryoablation is a safe and effective treatment for Barrett's esophagus.
See full descriptionAbout the trial for Barrett Esophagus
Treatment Groups
This trial involves 2 different treatments. CryoBalloon is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether CryoBalloon will improve 2 primary outcomes and 1 secondary outcome in patients with Barrett Esophagus. Measurement will happen over the course of 60 months.
Patient Q & A Section
What are the signs of barrett esophagus?
Barrett esophagus has many identifiable clinical features, and endoscopic findings that mimic barrett esophagus in the absence of GER can be life-threatening and require prompt medical attention.
What causes barrett esophagus?
This condition has no single cause or explanation, and has multiple possible causes that can interact in an individual. A small number of people are affected by this condition, and the exact cause is unknown.\n
What is barrett esophagus?
The diagnosis of BE may be missed, particularly considering that BE is a disorder that affects men at least 10 years earlier than BE. In fact, a subset of patients with BE were only identified based on their previous history with gastroesophageous reflux.
How many people get barrett esophagus a year in the United States?
Fewer than 200,000 cases of Barrett's esophagus are diagnosed in the United States each year. More than half of patients with a diagnosis of BE are female, and about one in twenty (5%) have a history of alcohol abuse. A history of BE is not strongly associated with any other major comorbidities and correlates more weakly with age.
What are common treatments for barrett esophagus?
The medical management of Barrett esophagus is aimed at optimizing the long-term outcome of esophageal healing and prevention of the development of Barrett's esophagus. There is limited evidence that the treatment of esophageal strictures/reflux esophagitis improves the long-term esophageal healing outcomes.
Can barrett esophagus be cured?
In conclusion, many (approximately 70%) of patients with Barrett esophagus can expect recovery of a normal esophagus at 3 years of follow-up. The cause of the refluxate esophagus may be the underlying cause of the BE. Patients who initially had BE and who are diagnosed with BE later, ie, 4 to 8 years after the onset of BE, may not have BE at 3 years of follow-up.
How does cryoballoon work?
Results from a recent paper of this study suggest that the cryo balloon is effective in preventing new or restenotic strictures in the long term. The cryotherapy also achieves adequate dilatation of the strictures.
Have there been any new discoveries for treating barrett esophagus?
Treatments that aim to prevent [reflux esophagitis] are currently being used ("i.e." fundoplication and proton-pump inhibitors). While there are few controlled trials comparing fundoplication/proton-pump inhibitors with new treatments, we are confident that [power] will provide your clinician with recent evidence. New treatments are now available in the United States and Europe, but none have shown a positive response in randomized controlled trials. Therefore, additional work is needed for these new treatments to be recognized as standard of care.
Does barrett esophagus run in families?
These data do not support the view that there is a genetic component to BE and, therefore, suggest that factors other than genetics contribute to this complication.
What are the chances of developing barrett esophagus?
The chance of developing Barrett esophagus depends on a number of individual factors. However, there was a statistically significant difference in the prevalence of Barrett esophagus among patients with esophageal adenocarcinoma, when compared with the prevalence of Barrett esophagus in patients with reflux disease and/or esophageal squamous cell neoplasia.
What is the latest research for barrett esophagus?
There's not enough research to establish whether medical treatments like gastric electrical stimulation and botulinum toxin injections help alleviate the symptoms of the heartburn and acid reflux associated with Barrett's esophagus. Overall, the research suggests Barrett's esophagus does cause significant discomfort but does not typically pose immediate health risks associated with esophageal cancer. However, it is necessary to note that the studies referenced above were limited in terms of overall quality, so there may be more research needed. It's important to remember that for Barrett's esophagus to develop into esophageal cancer, most experts agree that it must be present for 10 years and in other cases, the esophagus may already have metaplastic changes.