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SpeakFree Heat and Moisture Exchanger (HME)

NCT05349487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).

Conditions

  • Laryngeal Cancer
  • Laryngectomy

Interventions

DEVICE

SpeakFree HME Hands Free Valve

A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.

OTHER

Digital Occlusion

Using participant's own fingers, they will be putting their fingers over the stoma.

DEVICE

Digital Depression HME

A digital handheld press-down HME will be placed over stoma.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Mario A Landera, SLP.D. · University of Miami

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2025-01-30
Completion
2025-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349487 on ClinicalTrials.gov