NCT07369050

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
51mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Laryngectomy

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion; an average of 1 year

Study Arms (3)

Routine "as needed" exchange with Provox ActiValve

EXPERIMENTAL

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

Device: Provox® ActiValve®

Standard indwelling VP with optional cross-over to Provox ActiValve

EXPERIMENTAL

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

Device: Provox® ActiValve®

Prophylactic Provox ActiValve exchange

EXPERIMENTAL

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.

Device: Provox® ActiValve®

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.

Prophylactic Provox ActiValve exchangeRoutine "as needed" exchange with Provox ActiValveStandard indwelling VP with optional cross-over to Provox ActiValve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture
  • Using or ready for fit of indwelling voice prosthesis
  • No evidence of disease (NED) in head and neck
  • At least 6 months since cancer treatment
  • TEP tract length 4.5 to 12.5mm at time of enrollment\*
  • The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site's standard clinical practice (e.g. appearance/fit and/or depth gauge).

You may not qualify if:

  • History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)
  • History of recurrent VP extrusion (within last 12 months)
  • Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)
  • History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)
  • Active malignancy in head and neck and/or chest at the time of enrollment
  • Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment
  • Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons
  • Planned regular VP exchanges at outside facility within next 12 months
  • History of gastric pull-up reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77090, United States

Location

Related Links

Study Officials

  • Katherine A Hutcheson, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A Hutcheson, PHD

CONTACT

(713) 792-6513karnold@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 27, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2030

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

US(1)