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NCT00743262 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2023-07-25

The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Short-term Feasibility Provox Vega 22.5 French

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outcome · POSTED

Subjective Voice and Speech Quality

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outcome · POSTED

Device Life Time

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Total laryngectomy * Use Provox ActiValve Exclusion Criteria: * Current problems with TE puncture
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Device: Provox voice prosthesis
    label
    Provox voice prosthesis
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Provox voice prosthesis
    description
    The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted
    name
    Provox voice prosthesis
    other Names
    1. Indwelling voice prosthesis
    type
    DEVICE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
15
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Short-term Feasibility Provox Vega 22.5 French
    time Frame
    3 weeks
secondary Outcomes
  1. description
    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.
    measure
    Subjective Voice and Speech Quality
    time Frame
    3 weeks
  2. description
    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.)
    measure
    Device Life Time
    time Frame
    one year
Full study description
brief Summary
The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-1f45a38796a07e640667
      requested nct id
      NCT00743262
      primary nct id
      NCT00743262
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      payload sha256
      40f291657ef1e4fe9f81402b4f0c39eb4b5cb6eba03e381212f0a2432da6ee89
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-1f45a38796a07e640667
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00743262
      occurrences
      1. context exact
        NCT00743262
        end
        11
        exact text
        NCT00743262
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      source json pointer
      /studies/53/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c703d7307f2ca1afcc05ea0c0f2a5306968b387a7a7de535101070b4dd8e40e3

    Preserved source evidence · Not medical advice