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NCT02437513 · OUTCOME

Number of Reported Adverse Events

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
AE reported
Interval / dispersion
Not reported
Time frame
2 weeks

What was measured

Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period

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
NewBreez2

Reported measurements

Source class 1
Values in AE reported · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NewBreez2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period
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
reporting Status
POSTED
time Frame
2 weeks
title
Number of Reported Adverse Events
type
SECONDARY
unit Of Measure
AE reported

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

Preserved source evidence · Not medical advice