Evaluation of the Safety of the Medical Device Simeox®

NCT02061852 | Terminated

• 1 other identifier: 2014-A00079-38
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety of the simeox®

  Adverse events related or not to the simeox®

  Day 8

Study Arms (2)

Physiotherapy

ACTIVE COMPARATOR

Traditional techniques

Device: Simeox; Procedure: Physiotherapy

simeox

EXPERIMENTAL

Medical device

Device: Simeox; Procedure: Physiotherapy

Interventions

Simeox DEVICE

Physiotherapy; simeox

Physiotherapy PROCEDURE

Physiotherapy; simeox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 pneumothorax during the last month.
• Pregnant or lactating women.
• Patient with a disability and/or unwillingness to follow protocol requirements.

Sponsors & Collaborators

• Physio-Assist: lead
• CEISO: collaborator
• University Hospital, Marseille: collaborator

Study Sites (1)

CHU Nord

Marseille, 13915 Cedex 20, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis; Ciliary Motility Disorders; Bronchitis, Chronic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Martine Reynaud-Gaubert, Prof.

  Hospital Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 13, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

FR (1)