Trial Outcomes & Findings for Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis (NCT NCT00743262)

Results Overview

Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

3 weeks

Results posted on

2023-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Provox Vega 22.5 French A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Provox Vega 22.5 French n=15 Participants A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	65.33 years STANDARD_DEVIATION 12.03 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment Netherlands	15 patients n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.

Outcome measures

Outcome measures
Measure	Provox Vega 22.5 French n=15 Participants A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
Short-term Feasibility Provox Vega 22.5 French	15 Patients

SECONDARY outcome

Timeframe: 3 weeks

Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.

Outcome measures

Outcome measures
Measure	Provox Vega 22.5 French n=15 Participants A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
Subjective Voice and Speech Quality	6 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: one year

Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)

Outcome measures

Outcome measures
Measure	Provox Vega 22.5 French n=15 Participants A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
Device Life Time	39.7 days Standard Deviation 33

Adverse Events

Provox Vega 22.5 French

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: +31-20-5252550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place