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NCT00661570 · OUTCOME

Ease of Insertion

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
NUMBER
Unit
insertions
Interval / dispersion
Not reported
Time frame
assessed immediately after insertion procedure

What was measured

The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.

Analysis population: All patients included for insertion evaluation

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 2026

Reported measurements

Not difficult at all
Values in insertions · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Provox Vega 2020Not reportedNot reportedNot reportedNot reported
A little difficult
Values in insertions · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Provox Vega 204Not reportedNot reportedNot reportedNot reported
Rather difficult
Values in insertions · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Provox Vega 201Not reportedNot reportedNot reportedNot reported
Very difficult
Values in insertions · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Provox Vega 201Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Not difficult at all
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    A little difficult
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Rather difficult
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Very difficult
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.
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
NUMBER
population Description
All patients included for insertion evaluation
reporting Status
POSTED
time Frame
assessed immediately after insertion procedure
title
Ease of Insertion
type
SECONDARY
unit Of Measure
insertions

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

Preserved source evidence · Not medical advice