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NCT01456143 · OUTCOME

Specificity

Optical Imaging of Head and Neck Cancer · Source last updated 2018-02-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Percent of images with correct diagnosis
Interval / dispersion
95% Confidence Interval
Time frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)

What was measured

Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results

Groups in this outcome

HRME With Proflavine

High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
HRME With Proflavine33

Reported measurements

Source class 1
Values in Percent of images with correct diagnosis · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HRME With Proflavine95Not reported9099Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        99
        value
        95
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
dispersion Type
95% Confidence Interval
groups
  1. description
    High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
    id
    OG000
    title
    HRME With Proflavine
param Type
MEAN
reporting Status
POSTED
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
title
Specificity
type
PRIMARY
unit Of Measure
Percent of images with correct diagnosis

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice