Phase 1 N=20 Treatment

Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

Total Laryngectomy

Bottom Line

View on ClinicalTrials.gov: NCT00942903 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: Patient Preference for Provox HME or Provox XtraHME — 12; 3; 5 Patients

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Provox Xtra HME (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Atos Medical AB
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Preference for Provox HME or Provox XtraHME	12; 3; 5	—
SECONDARY Noise at Stoma Occlusion	20; 0	—

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.

Eligibility Criteria

Inclusion Criteria

total laryngectomy
compliant Provox HME user (24/7 use)

Exclusion Criteria

current medical problems that might influence HME use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00942903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.