Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

Status unconfirmed · Phase 2

Conditions studied: Barrett's Esophagus

In brief

The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Key facts

Study ID

NCT02018367

Run by

Anandasabapathy, Sharmila, M.D.

People needed

100

Starts

2012-09-01

Expected to finish

2021-12-01

Last updated by the study team

2021-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.

You may not qualify if…

• Allergy or prior reaction to the fluorescent contrast agent proflavine
• Patients who are unable to give informed consent.
• Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion > 2 cm in size not amenable to EMR
• Patients with a history of a severe allergic reaction (anaphylaxis)
• Patients unable to undergo routine endoscopy with biopsy :
• Women who are pregnant or breastfeeding
• Prothrombin Time > 50% of control; PTT > 50 sec, or INR > 2.0)
• Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other
• Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
• Patients with known severe esophagitis
• Patients with suspected but no biopsy confirmed BE

Where it is running

• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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