Peripal System - Human factors validation testing
Research type
Research Study
Full title
Human Factors Validation Testing for the Peripal System; a manual connection assist device for peritoneal dialysis devices.
IRAS ID
235715
Contact name
Sandra Neumann
Contact email
Sponsor organisation
Peripal AG
Clinicaltrials.gov Identifier
2017-004000-21, EUDRACT
Duration of Study in the UK
0 years, 0 months, 22 days
Research summary
The Peripal System has been developed to aid the connection of dialysis catheters with dialysis bags and patient lines for patients undergoing Continuous Ambulant Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Chronically ill dialysis patients are often very frail and can find the manual connection of the dialysis catheter and dialysis bag/line difficult. This can result in the patients having to travel to have the procedure performed in a health care setting. The Peripal System aims to simplify the connection process, and could result in more patients being able to undergo dialysis in their home, thus reducing the burden on the patient and Health Authority. In this study we aim to assess the user interface of the Peripal System, to see if it can be used by its intended users without serious use errors or problems in a realistic simulated environment.
REC name
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0256
Date of REC Opinion
4 Jan 2018
REC opinion
Further Information Favourable Opinion