Bearpac Medical, LLC has launched the AESOP clinical trial, which stands for Assessing Experience, Safety, and Outcomes of the Passio Pump Drainage System.

This single-center, crossover, non-blinded, 1:1 randomized controlled trial is being conducted at North Bristol NHS Trust. Participants will be randomly assigned to receive IPC insertion using either the Bearpac Passio catheter or a standard BD PleurX catheter.

The primary goal of the trial is to evaluate the safety, efficacy, and tolerability of the Passio Pump Drainage System in comparison to the BD PleurX Pleural Catheter System.

A secondary objective is to assess the overall patient experience with the Passio Pump Drainage System.

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump), and a Disposable Collection Kit. It is designed for draining recurrent and symptomatic malignant ascites as well as recurrent and symptomatic pleural effusions.

The system allows patients to manage flow and vacuum during therapy via the handheld control unit.

It offers an advantage by delivering therapy at lower vacuum pressures, using an electronically controlled fluid management system, compared to the traditional vacuum bottle technology employed by competing devices.

The AESOP trial aims to provide valuable insights into patient experience and preferences, which are important for demonstrating the value of new technology to clinicians. This feedback will benefit Bearpac Medical and its future customers.

 

 

Source: prnewswire.com

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