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 range18 Years – 95 Years

SexALL

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

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