Point of Care Peritoneal Dialysis System Early Evaluation Study

Not Applicable

Recruiting

• Conditions: Peritoneal Dialysis; End Stage Kidney Disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12622000078752
• Lead Sponsor: Ellen Medical Devices Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-21
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patient Participants:
1. Aged between 18 years and 80 years (inclusive);
2. Willing and able to participate in the study;
3. Treated with peritoneal dialysis for a minimum of 6 months (either automated peritoneal dialysis or continuous ambulatory peritoneal dialysis);
4. Able to speak sufficient English to be trained safely in the EM-POC dialysis system and understand the training materials;
5. Provide written informed consent;
6. At-home requirements: The participant’s home must have an electricity supply and a supply of potable water.
7. Received a full course of vaccinations against COVID-19 as per contemporary NSW Health advice

Clinician Participants:
1. Physicians or nursing staff with at least 12 months experience of PD

Exclusion Criteria

Patient participants:
1. Expecting a planned procedure, dialysis modality change or transplant during the study;
2. Any condition or anticipated complication which in the opinion of the investigator would prevent compliance with study protocols or completion of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified