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TerminatedNCT02061852SIMETOLUpdated Oct 18, 2019

Evaluation of the Safety of the Medical Device Simeox®

An interventional study of Simeox and Physiotherapy in Broncho-degenerative Disease, Chronic Obstructive Airway Disease and Cystic Fibrosis, sponsored by Physio-Assist. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by Physio-Assist · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Broncho-degenerative Disease
  • Chronic Obstructive Airway Disease
  • Cystic Fibrosis
  • Idiopathic Bronchiectasis
  • Ciliary Dyskinesia
  • Chronic Bronchitis
03

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 15 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Physio-Assist is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Physiotherapy

    Traditional techniques

    Device: Simeox · Procedure: Physiotherapy

  • Experimental
    simeox

    Medical device

    Device: Simeox · Procedure: Physiotherapy

Interventions

  • DeviceSimeox
  • ProcedurePhysiotherapy
06

What researchers measure

Primary outcomes

  1. Safety of the simeox®

    Adverse events related or not to the simeox®

    Time frame: Day 8

07

Study locations

1 site
  • CHU Nord
    Marseille, 13915 Cedex 20, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02061852
Lead sponsor
Physio-Assist
Collaborators
CEISO, University Hospital, Marseille
Responsible party
Sponsor
First posted
Feb 13, 2014
Start date
Jul 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Oct 18, 2019

Study contacts

Martine Reynaud-Gaubert, Prof.
principal investigator · Hospital Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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