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NCT02437513 · OUTCOME

Change From Baseline Per Patient of Number and Severity of Aspiration 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
12 weeks

What was measured

In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12

Analysis population: First patient: Device was explanted within 48 hours after implantation - no Data could be collected Second Patient: Due to patient's non-compliance no data could be collected.Device was explanted within two weeks after implantation.

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
NewBreez0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
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
population Description
First patient: Device was explanted within 48 hours after implantation - no Data could be collected Second Patient: Due to patient's non-compliance no data could be collected.Device was explanted within two weeks after implantation.
reporting Status
POSTED
time Frame
12 weeks
title
Change From Baseline Per Patient of Number and Severity of Aspiration Events
type
PRIMARY

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

Preserved source evidence · Not medical advice