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

NCT06937216 | Not Yet Recruiting FDA Device

• 2 other identifiers: BXU602317CIV-25-04-052074
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchiectasis Adult; COPD

Keywords

Volara; OLE Therapy; mucous clearance

Outcome Measures

Primary Outcomes (1)

• Change in mucus plug volume (mL)

  Assessed based on movement of mucus plugs and/or clearance from segmental airways

  28 Days

Study Arms (1)

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

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

Single Group Assignment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Medimprove

Kontich, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Danielle Endres, RN

CONTACT

+13157296141; danielle_endres@baxter.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be a single arm, monocentric, prospective, pilot study.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)