Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Dia… (NCT04295811) | Clinical Trial Compass
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Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC
United States470 participantsStarted 2020-06-18
Plain-language summary
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)
Who can participate
Age range50 Years
SexMALE
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Inclusion criteria
✓. Men aged 50 years and above
✓. ≥5 years either of
✓. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
✓. One or more of the following:
✓. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
✓. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
✓. Indicated for surveillance EGD or for therapeutic EGD
✓. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD
Exclusion criteria
✕. Inability to provide written informed consent
✕. On anti-coagulant drug(s) that cannot be temporarily discontinued
✕. Known history of esophageal varices or esophageal stricture
✕. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula, and/or esophageal ulceration
What they're measuring
1
Primary Efficacy
Timeframe: Per subject analysis through study completion which is up to approximately 5 weeks