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

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ClinicalTrials.gov Identifier: NCT02061852
Recruitment Status : Terminated
First Posted : February 13, 2014
Last Update Posted : October 21, 2015
Sponsor:
Collaborators:
CEISO
University Hospital, Marseille
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Broncho-degenerative Disease Chronic Obstructive Airway Disease Cystic Fibrosis Idiopathic Bronchiectasis Ciliary Dyskinesia Chronic Bronchitis Device: Simeox Procedure: Physiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Active Comparator: Physiotherapy
Traditional techniques
Device: Simeox
Procedure: Physiotherapy
Experimental: simeox
Medical device
Device: Simeox
Procedure: Physiotherapy



Primary Outcome Measures :
  1. Safety of the simeox® [ Time Frame: Day 8 ]
    Adverse events related or not to the simeox®



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061852


Locations
France
CHU Nord
Marseille, France, 13915 Cedex 20
Sponsors and Collaborators
Physio-Assist
CEISO
University Hospital, Marseille
Investigators
Principal Investigator: Martine Reynaud-Gaubert, Prof. Hospital Marseille

Responsible Party: Physio-Assist
ClinicalTrials.gov Identifier: NCT02061852     History of Changes
Other Study ID Numbers: 2014-A00079-38
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Cystic Fibrosis
Dyskinesias
Bronchitis
Bronchiectasis
Bronchitis, Chronic
Lung Diseases, Obstructive
Ciliary Motility Disorders
Pulmonary Disease, Chronic Obstructive
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities