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

This study has been terminated.
Sponsor:
Collaborators:
CEISO
University Hospital, Marseille
Information provided by (Responsible Party):
Physio-Assist
ClinicalTrials.gov Identifier:
NCT02061852
First received: January 31, 2014
Last updated: October 20, 2015
Last verified: October 2015
  Purpose
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 Intervention
Broncho-degenerative Disease
Chronic Obstructive Airway Disease
Cystic Fibrosis
Idiopathic Bronchiectasis
Ciliary Dyskinesia
Chronic Bronchitis
Device: Simeox
Procedure: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Physio-Assist:

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


Enrollment: 15
Study Start Date: July 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physiotherapy
Traditional techniques
Device: Simeox Procedure: Physiotherapy
Experimental: simeox
Medical device
Device: Simeox Procedure: Physiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Physio-Assist
ClinicalTrials.gov Identifier: NCT02061852     History of Changes
Other Study ID Numbers: 2014-A00079-38
Study First Received: January 31, 2014
Last Updated: October 20, 2015

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

ClinicalTrials.gov processed this record on April 27, 2017