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NCT00661570 · REGISTRY CONDITION SEARCH

Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 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
NA
Status at capture
TERMINATED
Registry last update
2017-03-10

The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.

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

Device Life Time

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outcome · POSTED

Voice Quality

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outcome · POSTED

Ease of Insertion

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outcome · POSTED

Reason for Replacement

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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 Provox2 voice prosthesis * at least two prior prosthesis changes Exclusion Criteria: * current puncture problems (f. ex. infection)
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Device: Provox Vega voice prosthesis (20 Fr)
    label
    Early feasability arm
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Early feasability arm
    description
    The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system
    name
    Provox Vega voice prosthesis (20 Fr)
    other Names
    1. indwelling Provox voice prosthesis
    type
    DEVICE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
26
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Device Life Time
    time Frame
    at replacement of voice prosthesis (maximum 1 year)
secondary Outcomes
  1. description
    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.
    measure
    Voice Quality
    time Frame
    at 3 months or device change (whichever was first)
  2. description
    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.
    measure
    Ease of Insertion
    time Frame
    assessed immediately after insertion procedure
  3. measure
    Reason for Replacement
    time Frame
    At removal of prosthesis
Full study description
brief Summary
The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-3f7e1312e48d2182c54a
      requested nct id
      NCT00661570
      primary nct id
      NCT00661570
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      payload sha256
      6363a623a980f05293417a58ae613b67a91c67bd96f8807303024e6bc40b637f
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-3f7e1312e48d2182c54a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00661570
      occurrences
      1. context exact
        NCT00661570
        end
        11
        exact text
        NCT00661570
        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/17/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      9facebcb9e60bd864bef9bdc75f9aed9da43804db708cf59cf05aac4e59ca893

    Preserved source evidence · Not medical advice