NCT00661570 · OUTCOME

Reason for Replacement

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.

Analysis population: 1 patient had his Vega inappropriately removed and received a Provox2.

Groups in this outcome

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	25

leakage through prosthesis

Values in patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Provox Vega 20	16	Not reported	Not reported	Not reported	Not reported

periprosthetic leakage due to smaller diameter

Values in patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Provox Vega 20	5	Not reported	Not reported	Not reported	Not reported

combination of causes

Values in patients · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Provox Vega 20	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

groups

param Type

NUMBER

population Description

1 patient had his Vega inappropriately removed and received a Provox2.

reporting Status

POSTED

time Frame

At removal of prosthesis

title

Reason for Replacement

type

SECONDARY

unit Of Measure

patients

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

Preserved source evidence · Not medical advice