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New treatment option for Barrett Esophagus
Official title Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
ClinicalTrials.gov ID: NCT06687603
What this study is testing
- What it's testing
- The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general...
- Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia; but who do have:
- Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
You likely can't join if
- History of prior EGD procedure in past ten years
- Inability to provide written informed consent
- History of weekly of more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having...
See the full eligibility criteria
- Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for...
- Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia; but who do have:
- Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
- Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years...
- people must have the ability to understand and the willingness to sign a written informed consent document.
- people must have the ability to understand and the willingness to sign a written informed consent document.
- History of prior EGD procedure in past ten years
- Inability to provide written informed consent
- History of weekly of more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities...
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Baltimore, Maryland, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Baltimore, Maryland, United States; Chapel Hill, North Carolina, United States; Cleveland, Ohio, United States. 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.