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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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.
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
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
Time frame: Through study completion; an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.