Evaluation of the Safety of the Medical Device Simeox®

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02061852

Acronym

SIMETOL

Enrollment

Registered

2014-02-13

Start date

2014-07-31

Completion date

2015-09-30

Last updated

2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis, Idiopathic Bronchiectasis, Ciliary Dyskinesia, Chronic Bronchitis

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.

Interventions

DEVICESimeox

PROCEDUREPhysiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026