NCT06311292

Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Daniel J. Weiner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum. Participants will use the Volara System during clinic visit in an attempt to produce sputum.

Detailed description

Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care. The purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	Volara System	Intrapulmonary percussive ventilation for mobilizing mucus.

Timeline

• Start date: 2024-05-29
• Primary completion: 2025-03-19
• Completion: 2025-03-19
• First posted: 2024-03-15
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study