Evaluation of the Safety of the Medical Device Simeox®

Not Applicable

Terminated

• Conditions: Broncho-degenerative Disease; Idiopathic Bronchiectasis; Ciliary Dyskinesia; Chronic Bronchitis; Chronic Obstructive Airway Disease; Cystic Fibrosis
• Interventions: Device: Simeox; Procedure: Physiotherapy

• Registration Number: NCT02061852
• Lead Sponsor: Physio-Assist

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Start: 2014-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	Traditional techniques
simeox	Physiotherapy	Medical device
Physiotherapy	Simeox	Traditional techniques
simeox	Simeox	Medical device

Primary Outcome Measures

Name	Time	Method
Safety of the simeox®	Day 8	Adverse events related or not to the simeox®

Trial Locations

Locations (1)

CHU Nord; 🇫🇷 Marseille, France