NCT07369050

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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®

Conditions

• Laryngectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study