Bearpac Medical Launches AESOP Clinical Trial
Bearpac Medical, LLC has begun the AESOP clinical trial to evaluate the experience, safety, and outcomes associated with the Passio Pump Drainage System. The study will be conducted at a single site recognized for its commitment to advancing care. Participants will be randomly assigned to use either the Bearpac Passio catheter or a conventional system, allowing a direct, head-to-head comparison under real-world conditions.
What the AESOP Trial Will Measure
The trial’s primary aim is to assess the safety and efficacy of the Passio Pump compared with the BD PleurX catheter system. Alongside clinical performance, the study will closely track how patients feel using the Passio Pump—what works, what’s comfortable, and where it helps most during drainage therapy. Those insights are intended to help clinicians better understand the value the system may offer from the patient’s point of view.
Inside the Passio Pump Drainage System
The Passio Pump Drainage System brings together three core components: the Passio Catheter, a Handheld Control Unit, and a Disposable Collection Kit. It is designed for patients managing recurrent malignant ascites and symptomatic pleural effusions. A defining feature of the system is its customizable control over flow and vacuum settings. With these controls available on the handheld unit, patients can adjust therapy within the parameters set by their care team, adding a measure of flexibility during use.
How the Technology Differs
A key advantage of the Passio system is its ability to operate at substantially lower vacuum pressures than traditional options. Instead of relying on vacuum bottles, the system uses electronically controlled fluid management. This design difference supports a more measured approach to drainage that is intended to enhance comfort while supporting clinical goals. It’s a shift from manual methods toward an electronic platform built to deliver consistent, controlled performance.
Keeping Patient Experience Front and Center
Jay Zimmerman, President of Bearpac Medical, emphasized that understanding patient experience and preferences is essential to showing clinicians the value of new technology. The AESOP trial is expected to generate practical, user-centered feedback. That input will guide how the Passio system is used in care settings and help Bearpac refine solutions that serve patients undergoing drainage therapy.
About Bearpac Medical, LLC
Bearpac Medical is a medical technology company focused on developing thoracic drainage products that support patients confronting pleural effusions. Located in New Hampshire, the company is dedicated to improving patient care through innovation and thoughtful design.
Media Contact
For media inquiries, please contact Kelly MacMillan at 833-232-7722.
Frequently Asked Questions
What is the AESOP clinical trial?
It’s a single-site clinical study launched by Bearpac Medical, LLC to evaluate the safety, efficacy, and patient experience of the Passio Pump Drainage System compared with a conventional approach.
What makes the Passio Pump different from traditional systems?
The Passio Pump uses an electronically controlled fluid management system and operates at substantially lower vacuum pressures than methods that rely on vacuum bottles. It also allows customizable control over flow and vacuum settings via a handheld unit.
Who is the Passio system designed for?
The system is designed for patients with recurrent malignant ascites and symptomatic pleural effusions, with components intended to support drainage therapy in those settings.
What are the main goals of the trial?
Primary goals include comparing the safety and efficacy of the Passio Pump to the BD PleurX catheter system and gathering detailed feedback on patients’ experiences with the Passio system.
How can someone learn about participating?
Interested individuals can seek information through the participating medical center conducting the single-site study to understand eligibility and trial requirements.
