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A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses 48 Randomizado

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07369050 é um estudo intervencionista para Laringectomia. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de julho de 2026, com o objetivo de incluir 48 participantes. Coordenado por o Centro de Câncer MD Anderson e deve ser concluído em 1 de setembro de 2030. Essas informações foram atualizadas no ClinicalTrials.gov em 27 de janeiro de 2026.
Resumo
The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.
Descrição detalhada

Primary Objective:

To determine whether routine use of Provox® ActiValve® voice prosthesis decreases annual number of clinical procedures to exchange VP in indwelling voice prosthesis users after total laryngectomy with TEP.

Secondary Objectives:

  1. To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator...
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Título oficial

Is the Provox ActiValve Only a Problem Solver? A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses After Total Laryngectomy With Tracheoesophageal Puncture

Condições médicas
Laringectomia
Outros IDs do estudo
  • 2025-1610
  • NCI-2026-00404 (Outro identificador) (NCI-CTRP Clinical Trials Registry)
Número NCT
NCT07369050
Data de início (real)
2026-07-01
Última atualização postada
2026-01-27
Data de conclusão (estimada)
2030-09-01
Inscrição (estimada)
48
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalRoutine "as needed" exchange with Provox ActiValve
Participants randomized to Arm 1 will receive a Provox® ActiValve® at the first VP replacement after randomization
Provox® ActiValve®
Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial.
ExperimentalStandard indwelling VP with optional cross-over to Provox ActiValve
Participants randomized into Arm 2 will receive their standard VP exchanges on "as needed" basis through the 12-month study period.
Provox® ActiValve®
Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial.
ExperimentalProphylactic Provox ActiValve exchange
Participants randomized to Arm 3 will receive a Provox® ActiValve® at the first VP replacement after randomization and prophylactic exchange will target replacement of the device between 9 months +/-1 month after fit.
Provox® ActiValve®
Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos

  1. Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture

  2. Using or ready for fit of indwelling voice prosthesis

  3. No evidence of disease (NED) in head and neck

  4. At least 6 months since cancer treatment

  5. TEP tract length 4.5 to 12.5mm at time of enrollment*

    • The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site's standard clinical practice (e.g. appearance/fit and/or depth gauge).

  1. History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)
  2. History of recurrent VP extrusion (within last 12 months)
  3. Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)
  4. History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)
  5. Active malignancy in head and neck and/or chest at the time of enrollment
  6. Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment
  7. Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons
  8. Planned regular VP exchanges at outside facility within next 12 months
  9. History of gastric pull-up reconstruction
M.D. Anderson Cancer Center logoCentro de Câncer MD Anderson
Contato central do estudo
Contato: Katherine A Hutcheson, PHD, (713) 792-6513, [email protected]
1 Locais do estudo em 1 países

Texas

The University of Texas M. D. Anderson Cancer Center, Houston, Texas, 77090, United States
Katherine A Hutcheson, PHD, Contato, 713-792-6513, [email protected]
Katherine A Hutcheson, PHD, Investigador principal