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New treatment option for Barrett Esophagus
Official title Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
ClinicalTrials.gov ID: NCT06071845
What this study is testing
- What it's testing
- This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening.
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 90
You may be able to join if
- people with known or suspected Barrett's esophagus (BE) (cases)
- Patients between the ages of 18-90.
- Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
- Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
- Undergoing clinically indicated endoscopy.
You likely can't join if
- For people with or without known evidence of BE (on history or review of medical records)
- Pregnant or lactating females.
- Patients who are unable to consent.
- Patients with current history of uninvestigated dysphagia.
- History of eosinophilic esophagitis, achalasia.
- Patients on oral anticoagulation including Coumadin, Warfarin.
See the full eligibility criteria
- people with known or suspected Barrett's esophagus (BE) (cases)
- Patients between the ages of 18-90.
- Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
- Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
- Undergoing clinically indicated endoscopy.
- people without known history of BE (controls)
- Undergoing clinically indicated diagnostic endoscopy
- For people with or without known evidence of BE (on history or review of medical records)
- Pregnant or lactating females.
- Patients who are unable to consent.
- Patients with current history of uninvestigated dysphagia.
- History of eosinophilic esophagitis, achalasia.
- Patients on oral anticoagulation including Coumadin, Warfarin.
- Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.
- Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.
- Patients with history of known esophageal or gastric varices or cirrhosis.
- Patients with history of surgical esophageal resection for esophageal carcinoma.
- Patients with congenital or acquired bleeding diatheses.
- Patients with a history of esophageal squamous dysplasia.
- Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
- Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- New Hyde Park, New York, 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, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States; New Hyde Park, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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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.