TerminatedNot Applicable

Staging of Superficial EAC Using VLE

Stopped: Device company went out of business

United States30 participantsStarted 2017-05-05

Plain-language summary

This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

Who can participate

Age range

18 Years – 95 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: * Patient over the age of 18 * Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus. * Ability to provide written, informed consent * No significant esophagitis (LA grade \<B, C, and D) Exclusion Criteria: * Patients who have achieved complete remission of intestinal metaplasia (CR-IM) * Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD) * Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use. * Prior esophageal or gastric surgical resection * Significant esophageal stricture requiring dilatation * Patients who require anticoagulation for who biopsy would be contraindicated * Patients who are known to be pregnant

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

Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion

Timeframe: 1 day

Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC

Timeframe: 1 day

Trial details

NCT IDNCT03385343

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-08

Results submitted2022-12-13

View on ClinicalTrials.gov More Esophageal Cancer trials

Who can participate

Age range

18 Years – 95 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.