RecruitingNot Applicable

Navicam for Detection of Barrett's Esophagus

United States57 participantsStarted 2025-02-20

Plain-language summary

Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Adults greater than or equal to 22 years of age with or without Barrett's Esophagus * All Patients: o Have had an endoscopy within 1 year of baseline enrollment * Patients with Barrett's Esophagus: * Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or * Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines Exclusion Criteria * Inability to comprehend or read the consent form * Have an oropharynx, esophageal, or gastro-esophageal tumor * Ongoing symptoms of dysphagia * Presence of active clinically significant stricture * History of stricture requiring dilation * Presence of pacemaker or implanted cardiac defibrillator * History of esophageal surgery with the exception of fundoplication * Pregnancy * History of surgery or obstructive process of the small bowel * BMI \> 38

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detection of Columnar lined epithelium in the esophagus

Timeframe: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..

Trial details

NCT IDNCT06748911

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Stephanie McNew

904-953-5080 McNew.Stephanie@mayo.edu

View on ClinicalTrials.gov More Barrett's Esophagus trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.