CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Provox Xtra 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.

Search/NCT00942903
NCT00942903Phase 1Completed
CompareCT.gov

Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy

Atos Medical AB·interventional·Posted Jul 21, 2009·Updated Oct 22, 2010

In Brief

A Phase 1 clinical trial evaluating Provox Xtra HME for Total Laryngectomy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Laryngectomy
CountriesNetherlands
CollaboratorsThe Netherlands Cancer Institute

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2009
Enrollment StartJul 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago

Interventions

Provox Xtra HMEdevice

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy