Trial Outcomes & Findings for Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis (NCT NCT00661570)

Results Overview

Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

at replacement of voice prosthesis (maximum 1 year)

Results posted on

2017-03-10

Participant Flow

Patients were recruited at the outpatient clinic when they came in for a voice prosthesis replacement.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Provox Vega 20 n=26 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	67.69 years STANDARD_DEVIATION 12.18 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment Netherlands	26 patients n=5 Participants

PRIMARY outcome

Timeframe: at replacement of voice prosthesis (maximum 1 year)

Population: In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.

Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.

Outcome measures

Outcome measures
Measure	Provox Vega 20 n=16 Participants 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.
Device Life Time	93 days of use Full Range 81.85 • Interval 3.0 to 279.0

SECONDARY outcome

Timeframe: at 3 months or device change (whichever was first)

Population: 23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.

Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.

Outcome measures

Outcome measures
Measure	Provox Vega 20 n=23 Participants 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.
Voice Quality	8.4 Units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: assessed immediately after insertion procedure

Population: All patients included for insertion evaluation

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.

Outcome measures

Outcome measures
Measure	Provox Vega 20 n=26 Participants 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.
Ease of Insertion Not difficult at all	20 insertions
Ease of Insertion A little difficult	4 insertions
Ease of Insertion Rather difficult	1 insertions
Ease of Insertion Very difficult	1 insertions

SECONDARY outcome

Timeframe: At removal of prosthesis

Population: 1 patient had his Vega inappropriately removed and received a Provox2.

Outcome measures

Outcome measures
Measure	Provox Vega 20 n=25 Participants 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.
Reason for Replacement leakage through prosthesis	16 patients
Reason for Replacement periprosthetic leakage due to smaller diameter	5 patients
Reason for Replacement combination of causes	4 patients

Adverse Events

Provox Vega 20

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. F.J.M. Hilgers

Netherlands Cancer Institute

Phone: +31-20-5122550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place