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New treatment option for Barretts Esophagus With Dysplasia
Official title Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
ClinicalTrials.gov ID: NCT05753748
What this study is testing
- What it's testing
- The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy.
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND: Meets all the following criteria will be eligible for...
- Male or female, age ≥18 years,
- Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1...
- Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,
- Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained...
You likely can't join if
- Pregnancy;
- Prior endoscopic eradication therapy for Barrett's esophagus;
- History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;
- History of esophageal resection/esophagectomy
- Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;
- Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due...
See the full eligibility criteria
- Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND: Meets all the following criteria will be eligible for enrollment:
- Male or female, age ≥18 years,
- Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas...
- Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,
- Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician),
- Demonstrated ability to tolerate proton pump inhibitor (PPI) therapy based on patient self-report, and, Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to...
- Pregnancy;
- Prior endoscopic eradication therapy for Barrett's esophagus;
- History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;
- History of esophageal resection/esophagectomy
- Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;
- Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy;
- Esophageal varices or known portal hypertension; and
- Life expectancy of \<2 years as judged by the site investigator. \ Presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. people with visible lesions will undergo endoscopic...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Oakland, California, United States
- San Jose, California, United States
- Aurora, Colorado, United States
- Sarasota, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- Manhasset, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Oakland, California, United States; San Jose, California, United States; Aurora, Colorado, United States; Sarasota, Florida, United States; Chicago, Illinois, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.