MOULTONBOROUGH, N.H., Sept. 10, 2024 /PRNewswire/ — Bearpac Medical, LLC is pleased to announce the launch of the AESOP clinical trial for Assessing Experience, Safety, and Outcomes of the Passio Pump Drainage System – (AESOP). AESOP is a single center, crossover, non-blinded 1:1 randomised controlled trial, recruiting at North Bristol NHS Trust. Participants will be randomised to IPC insertion with either a Bearpac Passio catheter or a standard catheter (BD PleurX).
The primary objective of the trial is safety, efficacy and tolerability of the Passio Pump Drainage System in comparison to the BD PleurX Pleural Catheter System. Secondary objective is to evaluate the overall experience of the Passio Pump Drainage System from a patient perspective.
The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, for drainage of recurrent and symptomatic malignant ascites as well as recurrent and symptomatic pleural effusions. Passio allows the patient to control flow and vacuum during their drainage therapy via the handheld control unit. The advantage of Passio is that it delivers the therapy at significantly lower vacuum pressures because of the electronically controlled fluid management system versus the uncontrolled vacuum bottle technology that competitive devices utilized for years.
“Understanding the patient experience and patient preferences is an important factor in communicating the value of new technology to the clinicians. AESOP will provide that user feedback to Bearpac and future customers,” said Jay Zimmerman, President of Bearpac Medical.
About Bearpac Medical, LLC
Bearpac Medical is a privately held medical technology company headquartered in New Hampshire, focused on the development of novel thoracic drainage products to improve the lives of patients experiencing pleural effusions. For more information, please visit www.bearpac.com.
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SOURCE Bearpac Medical, LLC