Provox ActiValve for Laryngectomy

Overseen By Katherine A Hutcheson, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active malignancy, Head/neck radiation, MRI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Katherine A Hutcheson, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone a total laryngectomy, which is surgery to remove the larynx or voice box. Participants should require a tracheoesophageal puncture (TEP) and be in need of a voice prosthesis device.

Inclusion Criteria

Using or ready for fit of indwelling voice prosthesis

I am over 18 and have had my voice box removed with a procedure to help me speak.

I have no signs of cancer in my head or neck.

Exclusion Criteria

I've had issues with my voice prosthesis leaking or the hole being too big in the last year.

I regularly get MRIs for cancer monitoring or other health issues.

I have had surgery to move my stomach up into my chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Provox® ActiValve® or standard indwelling voice prostheses with exchanges as needed

12 months

Regular visits for VP replacement as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Provox® ActiValve®

Trial Overview

The study aims to determine if using the Provox® ActiValve® regularly can reduce how often patients need their voice prosthesis devices replaced each year after having their larynx removed.

How Is the Trial Designed?

Group I: Standard indwelling VP with optional cross-over to Provox ActiValve Experimental Treatment 1 Intervention

Participants randomized into Arm 2 will receive their standard VP exchanges on "as needed" basis through the 12-month study period.

Group II: Routine "as needed" exchange with Provox ActiValve Experimental Treatment 1 Intervention

Participants randomized to Arm 1 will receive a Provox® ActiValve® at the first VP replacement after randomization

Group III: Prophylactic Provox ActiValve exchange Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+