Broncho-degenerative DiseaseSIMETOLNCT02061852
Evaluation of the Safety of the Medical Device Simeox®
A study testing Simeox and Physiotherapy in people with Broncho-degenerative Disease and Chronic Obstructive Airway Disease, run by Physio-Assist at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis
- What is being tested?
- Simeox and Physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis, Idiopathic Bronchiectasis, Ciliary Dyskinesia, Chronic Bronchitis
- Being tested
- Simeox, Physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis, Ciliary Motility Disorders, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimeoxDevice
PhysiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | Traditional techniques Receives: Device: Simeox; Procedure: Physiotherapy |
| simeox | Experimental | Medical device Receives: Device: Simeox; Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the simeox®
Adverse events related or not to the simeox®
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Broncho-degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physio-Assist
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO, University Hospital, Marseille
- Responsible party
- Sponsor
- Investigators
- Martine Reynaud-Gaubert, Prof., Principal investigator, Hospital Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061852
- Sponsor's protocol ID
- 2014-A00079-38
- Acronym
- SIMETOL
- Status last verified
- Oct 2019
- First submitted
- 31 Jan 2014
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02061852
- Acronym / sponsor ID
- SIMETOL / 2014-A00079-38
- Conditions
- Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis, Idiopathic Bronchiectasis, Ciliary Dyskinesia, Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Physio-AssistIndustry (pharma, biotech, devices)
- Collaborators
- CEISO, University Hospital, Marseille
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Device: Simeox, Procedure: PhysiotherapyTraditional techniques |
| simeox | Experimental | Device: Simeox, Procedure: PhysiotherapyMedical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simeox | Device | Physiotherapy, simeox |
| Physiotherapy | Procedure or surgery | Physiotherapy, simeox |
Primary outcome
Safety of the simeox®
Time frame: Day 8
Adverse events related or not to the simeox®
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Reynaud-Gaubert, Prof. principal investigator
Hospital Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simeox and Physiotherapy in people with Broncho-degenerative Disease and Chronic Obstructive Airway Disease, run by Physio-Assist at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the simeox® (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.