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NCT01045057 · OUTCOME

Success Rate of Procedure

Clinical Feasibility of New Tracheoesophageal Puncture Set · Source last updated 2021-06-11

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

Measure
NUMBER
Unit
Nr part. with succesful insertions
Interval / dispersion
Not reported
Time frame
immediate observation during surgery

What was measured

As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.

Analysis population: Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.

Groups in this outcome

Provox Vega Puncture Set

Patients with laryngeal cancer and a total laryngectomy in whom a TE puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set

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 Puncture Set27

Reported measurements

Source class 1
Values in Nr part. with succesful insertions · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Provox Vega Puncture Set23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
groups
  1. description
    Patients with laryngeal cancer and a total laryngectomy in whom a TE puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set
    id
    OG000
    title
    Provox Vega Puncture Set
param Type
NUMBER
population Description
Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
reporting Status
POSTED
time Frame
immediate observation during surgery
title
Success Rate of Procedure
type
PRIMARY
unit Of Measure
Nr part. with succesful insertions

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

Preserved source evidence · Not medical advice