Phase
Condition
Cystic Fibrosis
Scar Tissue
Lung Disease
Treatment
SIMEOX
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient diagnosed with Cystic fibrosis
Stabilization of the disease, defined by an at least 4 weeks period since the end ofan exacerbation, stabilization will be let to investigator's judgment.
Age >12
Requiring at least 1 bronchial clearing session each week (regardless of thetechnique)
Patient (or patient's legal representative if applicable), capable to read andunderstand the procedure, and capable to express consent for the study protocol.
Exclusion
Exclusion Criteria:
Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeksbefore the inclusion day.
Patient placed on a transplant waiting list
Any contraindication to an instrumental bronchial clearance technique
Patients already own and use SIMEOX at home
Unavailable patient or patient wishing to move to a different region within threemonths after inclusion.
Patient currently participating or having participated to another interventionalclinical research within a month prior inclusion date, that may impact the study,this impact is left to the investigator's judgment.
Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of theserum human chorionic gonadotropin level for any woman wishing to enter the protocoland under childbearing age < 60), parturient woman, breastfeeding mother, everyonedeprived of his liberty by judicial or administrative decision, everyone subject toa legal protection measure.
Initiation of treatment with a CFTR modulator within the last 3 months
Study Design
Connect with a study center
CHU Amiens Picardie
Amiens, 80054
FranceActive - Recruiting
CHU Angers
Angers, 49993
FranceActive - Recruiting
CHI Créteil
Créteil, 94000
FranceActive - Recruiting
Grenoble University Hospital : pneumo-pediatric department
Grenoble, 38043
FranceActive - Recruiting
Grenoble University-Affiliated Hospital : Pneumology department
Grenoble, 38043
FranceActive - Recruiting
CHU Lyon HCL
Lyon, 69495
FranceActive - Recruiting
Marseille University Hospital - Pneumology department
Marseille, 13005
FranceCompleted
Montpellier Hospital Center
Montpellier, 34000
FranceSuspended
Nice University-Affiliated Hospital : Pneumo-pediatric department
Nice, 06200
FranceActive - Recruiting
Nice University-Affiliated Hospital : Pneumology department
Nice, 06002
FranceActive - Recruiting
Hôpital Armand-Trousseau
Paris, 75012
FranceActive - Recruiting
Hôpital Robert Debré
Paris, 75019
FranceActive - Recruiting
CHU Reims
Reims, 51092
FranceActive - Recruiting
Fondation Ildys
Roscoff, 29684
FranceActive - Recruiting
CHU Felix Guyon
Saint-Denis, 97400
FranceActive - Recruiting
CHU De la Réunion Site SUD
Saint-Pierre, 97448
FranceActive - Recruiting
CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant
Saint-Pierre, 97448
FranceActive - Recruiting
CHU Toulouse - Hôpital Larrey
Toulouse, 31059
FranceActive - Recruiting
CHU Toulouse pediatric
Toulouse, 31059
FranceCompleted
Groupement Hospitalier Brocéliande Atlantique
Vannes, 56017
FranceActive - Recruiting
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