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

NCT07369050 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-27

No results posted yet for this study

Summary

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.

Conditions

  • Laryngectomy

Interventions

DEVICE

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Katherine A Hutcheson, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-09-01
Completion
2030-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369050 on ClinicalTrials.gov