Status:
COMPLETED
Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis
Lead Sponsor:
Physio-Assist
Conditions:
Cystic Fibrosis in Children
Airway Clearance Impairment
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the ...
Eligibility Criteria
Inclusion
- Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology
- willing and able to cooperate and learn new technic of drainage.
- age 8-18 years, on the date of admission to hospital.
- confirmed diagnosis of CF as determined by the investigator.
- able to perform pulmonary tests
Exclusion
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following:
- contraindications to bronchial chest physiotherapy
- hemoptysis
- pneumothorax
- heart disease
- recent chest surgery
- recent chest injury
- history of lung transplantation
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04084041
Start Date
September 10 2019
End Date
February 15 2021
Last Update
September 24 2025
Active Locations (1)
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1
IMiD
Warsaw, Poland