ABM Respiratory Care initiated a multicenter home care study to evaluate the impact of its BiWaze Clear System in patients living with bronchiectasis.
RT’s Three Key Takeaways:
- BiWaze Clear System: ABM Respiratory Care launched a national home care study to evaluate the BiWaze Clear System’s ability to reduce pulmonary exacerbations and improve quality of life in bronchiectasis patients.
- Decentralized Trial Model: In partnership with Delve Health, the study uses remote monitoring, wearable tech, and telemedicine to gather real-time data and reduce participation barriers.
- Alignment with Value-Based Care: The trial supports CMS priorities by showcasing how innovative home therapies can enhance outcomes, reduce hospital readmissions, and lower healthcare costs.
ABM Respiratory Care has initiated a multicenter home care study to evaluate the impact of its BiWaze Clear System in patients living with bronchiectasis. The study, performed in collaboration with Delve Health, will assess how the BiWaze Clear System affects respiratory health over a six-month period.
The FDA-cleared BiWaze Clear System delivers a combination of lung expansion, high frequency oscillation, and aerosol therapy designed to help patients mobilize and clear airway secretions. This post-market study will enroll approximately 85 patients across the United States, ages 5 to 85, replacing their existing airway clearance therapy with the BiWaze Clear System.
“Our goal is to demonstrate that BiWaze Clear can significantly reduce pulmonary exacerbations in bronchiectasis patients and improve their quality of life when used in the home setting,” said Leah Noaeill, Vice President of Marketing and Clinical Affairs at ABM Respiratory Care. “We’re excited to partner with Delve Health to capture meaningful data through remote monitoring, making it easier for patients and physicians to track therapy effectiveness in real time.”
The study highlights include:
- The BiWaze Clear System represents a new approach to airway clearance in the home care environment. This trial will validate its potential to transform treatment paradigms.
- Delve Health’s decentralized trial platform enables patients to participate remotely, reducing the burden of traditional clinical trials while ensuring a diverse and inclusive participant pool. Wearable integration and telemedicine capabilities will provide real-world data in real time.
- The trial aligns with CMS’s focus on value-based care and remote patient monitoring, demonstrating how innovative technologies like the BiWaze Clear can improve patient outcomes, reduce hospital readmissions, and lower healthcare costs.
- By combining ABMRC’s airway clearance system with Delve Health’s agile trial infrastructure, the partnership aims to deliver actionable insights faster, bringing life-changing respiratory solutions to market sooner.
The study will also collect safety data throughout the six-month therapy period, with oversight and adverse event reporting managed in accordance with FDA and ICH-GCP guidelines.
Wessam Sonbol, CEO of Delve Health, added, “At Delve Health, we believe the future of clinical trials is decentralized, digital, and patient-first. Partnering with ABM Respiratory Care on this trial allows us to bring that vision to life while supporting the development of a device that has the potential to revolutionize respiratory care and align with CMS’s goals for improved patient outcomes and cost efficiency.”
Patient enrollment will begin in May 2025, and the study is expected to run for 18 months.
Source: Delve Health
