Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02061852
Recruitment Status : Terminated
First Posted : February 13, 2014
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
CEISO
University Hospital, Marseille
Information provided by (Responsible Party):
Physio-Assist

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 13, 2014
Last Update Posted Date October 18, 2019
Study Start Date  ICMJE July 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Safety of the simeox® [ Time Frame: Day 8 ]
Adverse events related or not to the simeox®
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02061852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety of the Medical Device Simeox®
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Broncho-degenerative Disease
  • Chronic Obstructive Airway Disease
  • Cystic Fibrosis
  • Idiopathic Bronchiectasis
  • Ciliary Dyskinesia
  • Chronic Bronchitis
Intervention  ICMJE
  • Device: Simeox
  • Procedure: Physiotherapy
Study Arms  ICMJE
  • Active Comparator: Physiotherapy
    Traditional techniques
    Interventions:
    • Device: Simeox
    • Procedure: Physiotherapy
  • Experimental: simeox
    Medical device
    Interventions:
    • Device: Simeox
    • Procedure: Physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 20, 2015)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
20
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061852
Other Study ID Numbers  ICMJE 2014-A00079-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Physio-Assist
Study Sponsor  ICMJE Physio-Assist
Collaborators  ICMJE
  • CEISO
  • University Hospital, Marseille
Investigators  ICMJE
Principal Investigator: Martine Reynaud-Gaubert, Prof. Hospital Marseille
PRS Account Physio-Assist
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP