NCT00661570 · OUTCOME

Voice Quality

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: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: at 3 months or device change (whichever was first)

What was measured

Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.

Analysis population: 23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.

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

Group	Source count
Provox Vega 20	23

Reported measurements

Source class 1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Provox Vega 20	8.4	4.4	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
4.4
value
8.4

denoms

counts
group Id
OG000
value
23
units
Participants

description

Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.

dispersion Type

Standard Deviation

groups

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

MEAN

population Description

23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.

reporting Status

POSTED

time Frame

at 3 months or device change (whichever was first)

title

Voice Quality

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Not medical advice