The Passio Pump Drainage System has been shown to cause less pain to the patient during drainage therapy
Wijayaratne T, Hinchcliffe F, Rizvi S, et al S26 Feasibility and effectiveness of the Passio™ digital drainage system in reducing chest pain during IPC pleural drainage Thorax 2024;79:A24-A25.
AESOP TRIAL
Chief Investigator
Professor Nick Maskell
Professor of Respiratory Medicine / Honorary Consultant
Academic Respiratory Unit University of Bristol
Key Investigator
Dr Rahul Bhatnagar
Consultant Respiratory Physician /
Honorary Senior Lecturer
Academic Respiratory Unit University of Bristol
Trial Summary
Trial Title
Assessing Experience, Safety, and Outcomes of the Passio Pump Drainage System – an exploratory randomized controlled crossover study (AESOP)
Internal ref. no.
(or short title)
AESOP
Clinical Phase
Exploratory Study
Trial Design
Single-center, crossover, 1:1 randomized controlled trial
Trial Participants
Patients with a confirmed recurrent, symptomatic malignant effusion requiring long term, intermittent drainage with an indwelling pleural catheter.
Planned Sample Size
20 participants
Follow Up Duration
Four weeks
Planned Trial Period
12 month recruitment period
Primary Objective
To gather preliminary data regarding the safety, efficacy and tolerability of the Passio Pump Drainage System in comparison to the BD PleurX Pleural Catheter System
Secondary Objectives
Evaluate the safety of the Passio Pump Drainage System
Assess the efficacy of the Passio Pump drainage system compared to BD PleurX Pleural Catheter System
Evaluate patient reported outcomes of patients using the Passio system (subjective breathlessness and pain)
Exploratory Objective
Evaluate the overall experience of study involvement and use of the Passio Pump Drainage System from a patient perspective