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

Conditions

• Laryngectomy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Provox® ActiValve® — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Jan 2026

Primary completion

Sep 1, 2028

Completion

Sep 1, 2030

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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
• 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.
• 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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Katherine A Hutcheson, PHD
  (713) 792-6513
  [email protected]

Locations (1)

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