NCT01045057 · OUTCOME

Satisfaction of Physician

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: Number of times new set was preferred
Interval / dispersion: Not reported
Time frame: 1 month

What was measured

Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.

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 in whom 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

Group	Source count
Provox Vega Puncture Set	27

Reported measurements

Source class 1

Values in Number of times new set was preferred · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Provox Vega Puncture Set	26	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
26

denoms

counts
group Id
OG000
value
27
units
Participants

description

Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.

groups

description
Patients in whom 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

1 month

title

Satisfaction of Physician

type

SECONDARY

unit Of Measure

Number of times new set was preferred

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

Preserved source evidence · Not medical advice