Evaluation of the Safety of the Medical Device Simeox® (NCT02061852) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the Safety of the Medical Device Simeox®
France15 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.