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

January 23, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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)
  2. To compare outcomes, adverse events, and costs associated with prophylactic exchange of Provox® ActiValve® versus routine use of Provox® ActiValve® (experimental) or standard indwelling voice prostheses (comparator)

Exploratory objectives:

  1. To explore relationships between clinicodemographic features and device/TEP function
  2. To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function
  3. To explore relationships between oral/tracheal microbiome and device/TEP function
  4. To describe novel use of prophylactic exchange of Provox® ActiValve®

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77090
        • The University of Texas M. D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Katherine A Hutcheson, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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).

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine "as needed" exchange with Provox ActiValve
Participants randomized to Arm 1 will receive a Provox® ActiValve® at the first VP replacement after randomization
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.
Experimental: Standard 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.
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.
Experimental: Prophylactic 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Katherine A Hutcheson, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-1610
  • NCI-2026-00404 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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