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Trial record 3 of 9 for:    simeox

Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095078
Recruitment Status : Suspended (Study recruitment suspended during COVID-19 pandemia)
First Posted : September 19, 2019
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Icadom
Information provided by (Responsible Party):
Physio-Assist

Brief Summary:
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Pulmonary Cystic Fibrosis Device: SIMEOX Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, multicenter trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: SIMEOX
Use the device for 3 months in addition to usual care
Device: SIMEOX
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Pulmonary static hyperinflation assessed by residual volume [ Time Frame: Change from baseline at 3 months ]
    Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.


Secondary Outcome Measures :
  1. Use assessed by the duration of use of SIMEOX® device [ Time Frame: During 3 months of use ]
    Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • one of the 56 first patients of HOME-CARE SIMEOX study
  • same criteria as HOME-CARE SIMEOX study

Exclusion Criteria:

  • same criteria as HOME-CARE SIMEOX study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095078


Locations
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France
Grenoble University Hospital : pneumo-pediatric department
Grenoble, France, 38043
Grenoble University-Affiliated Hospital : Pneumology department
Grenoble, France, 38043
Montpellier Hospital Center
Montpellier, France, 34000
Nice University-Affiliated Hospital : Pneumology department
Nice, France, 06002
Nice University-Affiliated Hospital : Pneumo-pediatric department
Nice, France, 06200
Sponsors and Collaborators
Physio-Assist
Icadom
Investigators
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Principal Investigator: Boubou Camara, MD CHUGA
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Responsible Party: Physio-Assist
ClinicalTrials.gov Identifier: NCT04095078    
Other Study ID Numbers: Ancillary Home-Care SIMEOX
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Physio-Assist:
bronchial clearance
cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases