Status:
COMPLETED
Long Term Effects of Heat and Moisture Exchangers (HMEs)
Lead Sponsor:
Atos Medical AB
Collaborating Sponsors:
Instituto de Cancer Dr Arnaldo
Conditions:
Laryngectomy; Status
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
Eligibility Criteria
Inclusion
- Total laryngectomy, irrespective of pharynx reconstruction method
- 18 years or older
- Longer than 3 months after total laryngectomy
- Longer than 6 weeks after postoperative radiotherapy
Exclusion
- Current use of HMEs (within last 3 months)
- Medical problems prohibiting the use of HME
- Active recurrent or metastatic disease (medical deterioration)
- Recent pulmonary infections/unstable pulmonary condition
- Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
- Low tidal volumes
- Unable to understand the Participant Information and/or unable to give Informed Consent
Key Trial Info
Start Date :
March 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06084611
Start Date
March 26 2024
End Date
September 30 2025
Last Update
October 3 2025
Active Locations (1)
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1
Instituto de Cancer Dr. Arnaldo
São Paulo, Brazil