Evaluation of the Safety of the Medical Device Simeox®

Cystic Fibrosis Clinical Trial

— SIMETOL  

Official title:

Prospective Trial for the Evaluation of Safety, Tolerability and Efficacy of the Medical Device Simeox ® Compared to Traditional Respiratory Physiotherapy Techniques for Airway Secretion Clearance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02061852
• Other study ID #: 2014-A00079-38
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2019
• Source: Physio-Assist
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchitis
• Bronchitis, Chronic
• Broncho-degenerative Disease
• Chronic Bronchitis
• Chronic Obstructive Airway Disease
• Ciliary Dyskinesia
• Ciliary Motility Disorders
• Cystic Fibrosis
• Dyskinesias
• Idiopathic Bronchiectasis
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Simeox

Procedure:
• Physiotherapy

Locations

Country	Name	City	State
France	CHU Nord	Marseille

Sponsors (3)

Lead Sponsor	Collaborator
Physio-Assist	CEISO, University Hospital, Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the simeox®	Adverse events related or not to the simeox®	Day 8