Ancillary Home Airway Clearance in CF Patients ( HomeCare... | NCT04095078

Studies
Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

NCT04095078

Sponsor

Physio-Assist

Status

Completed

Last Update Posted

Jan 4, 2022Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Pulmonary Cystic Fibrosis

Interventions

SIMEOX

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2020Actual

Primary Completion Date

Sep 15, 2021Actual

Completion Date

Dec 15, 2021Actual

First Submitted Date

Sep 17, 2019

First Submission Date that Met QC Criteria

Sep 17, 2019

First Posted Date

Sep 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2022

Last Update Posted Date

Jan 4, 2022Actual

Name	Class
Icadom	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SIMEOX	Experimental	Use the device for 3 months in addition to usual care	Device: SIMEOX
Control	No Intervention	Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SIMEOX	Device	Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX	SIMEOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary static hyperinflation assessed by residual volume	Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.	Change from baseline at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Use assessed by the duration of use of SIMEOX® device	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.	During 3 months of use
Inspiratory capacity

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boubou Camara, MD	CHUGA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grenoble University Hospital : pneumo-pediatric department		Grenoble		38043	France
Grenoble University-Affiliated Hospital : Pneumology department

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided