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NCT00661570 · OUTCOME

Device Life Time

Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis · Source last updated 2017-03-10

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

Measure
MEDIAN
Unit
days of use
Interval / dispersion
Full Range
Time frame
at replacement of voice prosthesis (maximum 1 year)

What was measured

Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.

Analysis population: In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.

Groups in this outcome

Provox Vega 20

26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.

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

Analysis denominator · Participants

GroupSource count
Provox Vega 2016

Reported measurements

Source class 1
Values in days of use · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Provox Vega 209381.853279Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        spread
        81.85
        upper Limit
        279
        value
        93
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.
dispersion Type
Full Range
groups
  1. description
    26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
    id
    OG000
    title
    Provox Vega 20
param Type
MEDIAN
population Description
In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.
reporting Status
POSTED
time Frame
at replacement of voice prosthesis (maximum 1 year)
title
Device Life Time
type
PRIMARY
unit Of Measure
days of use

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

Preserved source evidence · Not medical advice