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NCT02437513 · OUTCOME

Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score

NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration · Source last updated 2017-08-24

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
1 weeks

What was measured

In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score: 0 = None 1. = Mild, some difficulty 2. = Moderate Difficulty but can continue 3. = Severe difficulty, cannot continue

Analysis population: Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.

Groups in this outcome

NewBreez

The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician. Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. NewBreez: Intralaryngeal prosthesis to protect the airways

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

Analysis denominator · Participants

GroupSource count
NewBreez1

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NewBreez1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score: 0 = None 1. = Mild, some difficulty 2. = Moderate Difficulty but can continue 3. = Severe difficulty, cannot continue
groups
  1. description
    The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician. Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. NewBreez: Intralaryngeal prosthesis to protect the airways
    id
    OG000
    title
    NewBreez
param Type
NUMBER
population Description
Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.
reporting Status
POSTED
time Frame
1 weeks
title
Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice