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NCT01384708 Clinical Trial

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

Squamous Cell Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01384708
Other study ID # GCO# 10-0982
Secondary ID
Status Completed
Phase Phase 0
First received June 28, 2011
Last updated January 7, 2016
Start date August 2010
Est. completion date October 2013

Study information
Verified date March 2014
Source Anandasabapathy, Sharmila, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- known or suspected squamous cell neoplasia

- 18 years or older

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• proflavine
1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)

Locations
Country Name City State
United States Mount Sinai Medical Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Anandasabapathy, Sharmila, M.D. William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to determine whether or not tissue is neoplastic or non-neoplastic 1 day No
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