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Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices

NCT04292210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-03-03

No results posted yet for this study

Summary

It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.

Conditions

  • End Stage Renal Failure on Dialysis
  • End Stage Renal Disease on Dialysis
  • Renal Failure
  • Peritoneal Dialysis
  • Renal Replacement Therapy

Interventions

DEVICE

Perisafe

A medical device simplifying the connection of tubing as well as breaking of the frangible which is done in a sterile environment with the help of levers and buttons.

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    collaborator OTHER

  • University Hospital Birmingham NHS Foundation Trust

    collaborator OTHER

  • Peripal AG

    lead INDUSTRY

Principal Investigators

  • Lukas Foggensteiner, MD, PhD · National Health Service, United Kingdom

  • Mirko Meboldt, PhD · ETH

  • Martin Dubach · Peripal AG

  • Stephan Hess · ETH

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-03-12
Completion
2018-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292210 on ClinicalTrials.gov