NCT01045057 · OUTCOME

Cost Effectiveness Calculation

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: MEAN
Unit: seconds
Interval / dispersion: Standard Deviation
Time frame: 1 month

What was measured

cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure

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 seconds · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Provox Vega Puncture Set	155.4	115.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
115.6
value
155.4

denoms

counts
group Id
OG000
value
27
units
Participants

description

cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure

dispersion Type

Standard Deviation

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

MEAN

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

Cost Effectiveness Calculation

type

SECONDARY

unit Of Measure

seconds

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

Preserved source evidence · Not medical advice