Evaluation of the Safety of the Medical Device Simeox® (SIMETOL)
Primary Purpose
Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Simeox
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Broncho-degenerative Disease
Eligibility 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.
Sites / Locations
- CHU Nord
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physiotherapy
simeox
Arm Description
Traditional techniques
Medical device
Outcomes
Primary Outcome Measures
Safety of the simeox®
Adverse events related or not to the simeox®
Secondary Outcome Measures
Full Information
NCT ID
NCT02061852
First Posted
January 31, 2014
Last Updated
October 16, 2019
Sponsor
Physio-Assist
Collaborators
CEISO, University Hospital, Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02061852
Brief Title
Evaluation of the Safety of the Medical Device Simeox®
Acronym
SIMETOL
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 Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physio-Assist
Collaborators
CEISO, University Hospital, Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis, Idiopathic Bronchiectasis, Ciliary Dyskinesia, Chronic Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Traditional techniques
Arm Title
simeox
Arm Type
Experimental
Arm Description
Medical device
Intervention Type
Device
Intervention Name(s)
Simeox
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Primary Outcome Measure Information:
Title
Safety of the simeox®
Description
Adverse events related or not to the simeox®
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Reynaud-Gaubert, Prof.
Organizational Affiliation
Hospital Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nord
City
Marseille
ZIP/Postal Code
13915 Cedex 20
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety of the Medical Device Simeox®
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