Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:45 AM
Study NCT ID:
NCT07369050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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®
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2026-00404 | OTHER | NCI-CTRP Clinical Trials Registry | View |