At a glance
ClinicalIndex Comparison RecordN/ACompleted· 16 enrolled
Drug / intervention
TW speaking valve/HMEdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Clinical Feasibility Study of a New Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients.
In Brief
A clinical study evaluating TW speaking valve/HME for Tracheostomy. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This clinical investigation addresses the performance of a re-designed The current study aims to investigate the next version of the TW speaking valve, in combination with both a 15mm and 22mm HME cassette.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTracheostomy
CountriesNetherlands
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedNov 2013
Primary CompletionApr 2014
TodayJul 2026
First PostedNov 6, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.7 years ago
Interventions
TW speaking valve/HMEdevice
The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and TW22 will be combined.