SpeakFree HME Hands Free Valve for Laryngectomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Laryngectomy+2 More
SpeakFree HME Hands Free Valve - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME) to other modalities of stomal occlusion for patients who communicate with a voice prosthesis, as determined by patient preference and satisfaction, and objective measures of speech and voice parameters.

Eligible Conditions
  • Laryngectomy
  • Laryngeal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 1 month

Baseline, 1 month
Change in Maximum Phonation Time
Change in Pressure Needed to Phonate
Change in Syllables Per Breath
Change in Voice Quality: Clinician Rating
Up to 1 month
Satisfaction as measured by VAS
Voice Quality: Patient Rating

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group
1 of 1
Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: SpeakFree HME Hands Free Valve · No Placebo Group · N/A

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve GroupExperimental Group · 3 Interventions: Digital Depression HME, Digital Occlusion, SpeakFree HME Hands Free Valve · Intervention Types: Device, Other, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month

Who is running the clinical trial?

University of MiamiLead Sponsor
787 Previous Clinical Trials
384,235 Total Patients Enrolled
Donna S Lundy, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have undergone a total laryngectomy at the University of Miami (UM) and use a voice prosthesis as your primary form of communication for at least 6 months prior to study enrollment.
Patients must demonstrate fluent tracheoesophageal speech (i.e.
You are willing to complete the survey and provide a signed Informed Consent Form.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.