Evaluation of the Effectiveness of The Volara System Dete... | NCT06937216

Studies
Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production

NCT06937216

Sponsor

Baxter Healthcare Corporation

Status

Not yet recruiting

Last Update Posted

Apr 22, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Bronchiectasis Adult
COPD

Interventions

Volara therapy

Countries

Belgium

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

ID	Type	Description	Link
CIV-25-04-052074	Other Identifier	Eudamed

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2025Estimated

Primary Completion Date

Sep 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Apr 15, 2025

First Submission Date that Met QC Criteria

Apr 15, 2025

First Posted Date

Apr 22, 2025Actual

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

Apr 15, 2025

Last Update Posted Date

Apr 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.

Detailed Description

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance. Mucus volume (mL) measured by Functional Respiratory Imaging (FRI). FRI is a quantitative endpoint that identifies mucus plugs in the segmented airways. Mucus volume will be assessed based on movement of mucus plugs and/or clearance from segmental airways. CT scans are obtained to determine FRI and will be obtained and assessed at baseline and after the 4-week treatment period to assess changes in mucus volume within the airways, associated with the Volara treatment. The study will also provide insight into the mechanism of action of the therapy.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Group Assignment	Experimental	Each participant will be his/her own control comparing their baseline status to an active treatment period.	Device: Volara therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Volara therapy	Device	Oscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

Measure	Description	Time Frame
Change in mucus plug volume (mL)	Assessed based on movement of mucus plugs and/or clearance from segmental airways	28 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of COPD with or without bronchiectasis.
Age ≥ 21 years.
Naive to Volara therapy.
FEV1 < 80% predicted (based on pulmonary function tests within the past 12 months).
Daily sputum production over the prior 2 weeks.
Signed informed consent.
Stable pulmonary disease defined as no change in disease status.
Stable medication regimen for 30 days prior to visit 1, defined as no change in prescribed medications and adherence to their prescribed medications for pulmonary disease

Exclusion Criteria:

Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
History of pneumothorax within the past 6 months prior to visit 1.
History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol.
Inability to complete a 6-minute walk.
Actively participating in another clinical trial involving an investigational medication or device.
Pregnant females as verified by point of care human chorionic gonadotropin test.
Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users.
Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
Participant requires mechanical ventilation.
Participants with artificial airways

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease