Evaluation of the Safety of the Medical Device Simeox®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiotherapy

Traditional techniques

Group Type ACTIVE_COMPARATOR

Simeox

Intervention Type DEVICE

Physiotherapy

Intervention Type PROCEDURE

simeox

Medical device

Group Type EXPERIMENTAL

Simeox

Intervention Type DEVICE

Physiotherapy

Intervention Type PROCEDURE

Interventions

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Simeox

Intervention Type DEVICE

Physiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No