CLINICAL TRIAL

CryoBalloon for Barrett Esophagus

Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether cryoablation is a safe and effective treatment for Barrett's esophagus.

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About the trial for Barrett Esophagus

Eligible Conditions
Esophageal Neoplasms · Barrett Esophagus · Esophageal Neoplasms Malignant · Esophageal Squamous Dysplasia · Esophagus, Barrett

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CryoBalloon
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 60 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 60 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Number of patients with treatment-related adverse events (pain and dysphagia)
60 MONTHS
evaluate by patient questionnaire for change from baseline in pain on the 11 point scale (0-10) from baseline to post treatment and incidence of dysphagia (using a standardized dysphagia scoring system 0-4) collected over treatment period.
60 MONTHS
Histological evaluation of treatment zone for intestinal metaplasia (BE patients)
60 MONTHS
evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation
60 MONTHS
Histological evaluation of treatment zone(s) for dysplasia
60 MONTHS
evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation
60 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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