Loading clinical trials...

TERMINATEDNA

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

NCT02061852•Physio-Assist

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+2 more criteria

Locations (1)

CHU Nord

Marseille, France

Key Dates

Start Date

July 1, 2014

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

October 18, 2019

Enrollment

ACTUAL participants

Conditions

Broncho-degenerative DiseaseChronic Obstructive Airway DiseaseCystic FibrosisIdiopathic BronchiectasisCiliary DyskinesiaChronic Bronchitis

Interventions

Simeox

DEVICE

Physiotherapy

PROCEDURE

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of the Safety of the Medical Device Simeox®

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population