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Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
NCT05753748 · View on ClinicalTrials.gov ↗
Study Summary
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. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 pa
Conditions Studied
Interventions
- PROCEDURE Endoscopic Eradication Therapy
Study Locations (20)
California
- University of California, Los Angeles — Los Angeles
- Kaiser Permanente Oakland Medical Center — Oakland
- Kaiser Permanente — San Jose
New York
- Long Island Jewish Medical Center — Manhasset
- Columbia Universtiy — New York
- University of Rochester Medical Center — Rochester
Ohio
- University Hospitals Cleveland Medical Center Case Western University — Cleveland
- Cleveland Clinic Foundation — Cleveland
Pennsylvania
- University of Pennsylania, Perelman School of Medicine — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Colorado
- University of Colorado — Aurora
Florida
- Florida Digestive Health Specialists — Sarasota
Illinois
- Northwestern Memorial Hospital — Chicago
Indiana
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2023-01-24 |
| Est. Completion | 2029-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05753748
The ClinicalTrials.gov registry entry for NCT05753748 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention — of which Endoscopic Eradication Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05753748 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05753748 about?
NCT05753748 is a clinical study titled "Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia". 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...
What is the current status of trial NCT05753748?
This trial is currently recruiting. It is a NA study. The enrollment target is 680 participants. The study started on 2023-01-24. Estimated completion is 2029-04-30.
What conditions does trial NCT05753748 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Barrett Esophagus, Barretts Esophagus With Dysplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05753748?
The interventions under investigation include: Endoscopic Eradication Therapy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05753748?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05753748 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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