Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

Early Phase 1

Completed

• Conditions: Squamous Cell Cancer
• Interventions: Drug: proflavine

• Registration Number: NCT01384708
• Lead Sponsor: Anandasabapathy, Sharmila, M.D.

Brief Summary

The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides \> 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-03
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• known or suspected squamous cell neoplasia
• 18 years or older

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	proflavine	imaging with proflavine

Primary Outcome Measures

Name	Time	Method
to determine whether or not tissue is neoplastic or non-neoplastic	1 day

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States