Evaluation of the Safety of the Medical Device Simeox® (SIMETOL)

PhysioAssist

Status: Terminated

Conditions: Ciliary Dyskinesia; Chronic Obstructive Airway Disease; Chronic Bronchitis; Idiopathic Bronchiectasis; Cystic Fibrosis; Broncho-degenerative Disease

Treatments: Procedure: Physiotherapy; Device: Simeox

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02061852

2014-A00079-38

Details and patient eligibility

About

The purpose of this study is to determine whether the medical device "simeox" is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18, male or female.
• Patient affected by broncho-degenerative disease, chronic obstructive airway disease, cystic fibrosis, idiopathic bronchiectasis, ciliary dyskinesia and/or chronic bronchitis.
• Hospitalization for a minimum of five days or a maximum of 8 days.
• Bronchial clearance is usually productive.
• FVC and / or FEV <85% predicted, with stable lung function.
• Agreement to participate to the study and signature of the informed consent form
• Social security coverage.

Exclusion criteria

• Patient infected with bacteria resistant to antibiotics.
• Bronchial clearance is not usually productive.
• Patient with contra-indication for physiotherapy bronchial clearance.
• Patient who received a lung transplant.
• Care requires more than 2 sessions of chest physiotherapy daily.
• Duration of mechanical ventilation > 8h/day.
• Patient with an episode of hemoptysis during the month before inclusion.
• Patient with an episode of pneumothorax during the last month.
• Pregnant or lactating women.
• Patient with a disability and/or unwillingness to follow protocol requirements.
• Patient participating in another clinical study or having tested an experimental drug within 30 days prior to his inclusion in the study.
• Patient ( s) with another condition which, according to the investigator , may interfere with the result or conduct of the trial and thus justify their non- inclusion in the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Physiotherapy

Active Comparator group

Description:

Traditional techniques

Treatment:

Device: Simeox

Procedure: Physiotherapy

simeox

Experimental group

Description:

Medical device

Treatment:

Device: Simeox

Procedure: Physiotherapy