Swallowable sponge device to detect Barrett's esophagus without endoscopy
Tests a swallowable sponge cell collector for finding Barrett's esophagus in adults.
Key facts
- Who runs it
- Mayo Clinic
- Where
- Chicago, Jacksonville, New Hyde Park, Rochester, and Scottsdale, United StatesSee the 5 sites
- Trial code
- Registry title
- Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
- Status
- Recruiting
- People taking part
- 450 people, planned
- Started
- 16 Oct 2023
- Expected to end
- 1 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cytosponge Procedure
- Endoscopic Assessment
- Record updated
- 2 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are having an endoscopy (a camera test of the food pipe) ordered by their doctor. It tests a swallowed sponge device, the Cytosponge. One group has known or suspected Barrett's esophagus. A control group has no known history of it.
- Age
- 18 to 90 years
- Sex
- All sexes
- Disease stage
- Case group: a Barrett's segment of ≥ 1cm (0.4 in) seen on endoscopy, or suspected Barrett's esophagus in the medical record. The tissue test shows intestinal metaplasia, with or without dysplasia (abnormal cells). Control group: no known history of Barrett's esophagus.
- Earlier treatment
- People who had surgery to remove part of the food pipe for esophageal cancer cannot join. People who had chemotherapy-type drugs or radiation for mediastinal or esophageal cancer cannot join. Blood thinners like Coumadin or Warfarin are not allowed. Clopidogrel, Dabigatran, rivaroxaban, apixaban or edoxaban are allowed only if stopped three to five days before the Cytosponge procedure.
Main reasons for not taking part
- Pregnant or breastfeeding
- Trouble swallowing that has not been checked by a doctor
- Eosinophilic esophagitis, achalasia, esophageal squamous dysplasia, or a bleeding disorder
- Swollen veins in the food pipe or stomach (varices), or cirrhosis
- Known cancer of the pancreas, bile duct, ampulla, stomach or duodenum within 5 years before enrollment
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- Subjects 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
- Subjects without known history of BE (controls); Undergoing clinically indicated diagnostic endoscopy
Who cannot take part
- For subjects 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in United States
- Northwestern UniversityChicago, United StatesContact: Clinical Trials Referral OfficeNo longer taking part
- Mayo Clinic in FloridaJacksonville, United StatesContact: Clinical Trials Referral OfficeTaking people
- Long Island Jewish Medical Center | Northwell HealthNew Hyde Park, United StatesContact: Clinical Trials Referral OfficeNo longer taking part
- Mayo Clinic in RochesterRochester, United StatesContact: Clinical Trials Referral OfficeTaking people
- Mayo ClinicScottsdale, United StatesContact: Clinical Trials Referral OfficeTaking people
About the trial
What the trial wants to find out
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. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
The 2 groups in the trial
- Known or Suspected Barrett's Esophagus (Case Arm)Treatment being tested
Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
Treatment: Cytosponge Procedure and Endoscopic Assessment
- No Known Barrett's Esophagus (Control Arm)Existing treatment, for comparison
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Treatment: Cytosponge Procedure and Endoscopic Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
- Plain-language title
- Swallowable sponge device to detect Barrett's esophagus without endoscopyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06071845, who can take part
- Record updated
- 2 June 2026