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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis; Chronic Bronchitis; Chronic Obstructive Airway Disease; Broncho-degenerative Disease; Idiopathic Bronchiectasis; Ciliary Dyskinesia
• Intervention / Treatment: Procedure: Physiotherapy; Device: Simeox

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13915 Cedex 20
    • CHU Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physiotherapy; Traditional techniques	Procedure: Physiotherapy; Device: Simeox
Experimental: simeox; Medical device	Procedure: Physiotherapy; Device: Simeox

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Physio-Assist
• Collaborators: University Hospital, Marseille; CEISO
• Investigators: Principal Investigator: Martine Reynaud-Gaubert, Prof., Hospital Marseille

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Neurologic Manifestations; Congenital Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Movement Disorders; Pancreatic Diseases; Abnormalities, Multiple; Ciliopathies; Bronchiectasis; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis; Dyskinesias; Bronchitis; Bronchitis, Chronic; Ciliary Motility Disorders
• Other Study ID Numbers: 2014-A00079-38