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Trial Outcomes & Findings for Long Term Use of the Provox Vega 22.5 (NCT NCT00884910)

NCT ID: NCT00884910

Last Updated: 2012-07-16

Results Overview

Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

3 months post insertion, or at end of device life (whichever comes sooner)

Results posted on

2012-07-16

Participant Flow

Patients were recruited by the Netherlands Cancer Institute

Participant milestones

Participant milestones
Measure
Provox Vega 22.5
The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
Overall Study
STARTED
33
Overall Study
COMPLETED
32
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Use of the Provox Vega 22.5

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Provox Vega 22.5
n=33 Participants
The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=5 Participants
Age, Categorical
>=65 years
18 Participants
n=5 Participants
Age Continuous
66.42 years
STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
32 Participants
n=5 Participants
Region of Enrollment
Netherlands
33 patients
n=5 Participants

PRIMARY outcome

Timeframe: 3 months post insertion, or at end of device life (whichever comes sooner)

Population: All patients that participated in the study and finished it were analyzed

Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".

Outcome measures

Outcome measures
Measure
Provox Vega 22.5
n=32 Participants
The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
Patient Preference
Provox Vega 22.5
14 Patients
Patient Preference
Provox2
7 Patients
Patient Preference
No preference
11 Patients

SECONDARY outcome

Timeframe: 6 months

Population: Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis.

Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.

Outcome measures

Outcome measures
Measure
Provox Vega 22.5
n=33 Participants
The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
Device Life Time
74 Days
Full Range 60.8 • Interval 8.0 to 184.0

Adverse Events

Provox Vega 22.5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Dr FJM Hilgers

Netherlands Cancer Institute

Phone: +31 20 512 2550

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place