Clinical Trials Directory

Trials / Completed

CompletedNCT02795286

Automated Setting of Individualized Sodium Technology

Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Vantive Health LLC · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.

Conditions

Interventions

TypeNameDescription
DEVICEArtis Haemodialysis Machine w/ ASIST Software - Isonatremic
DEVICEArtis Haemodialysis Machine w/ ASIST Software - Isotonic
DEVICEArtis Haemodialysis Machine w/o ASIST Software

Timeline

Start date
2016-03-01
Primary completion
2016-11-01
Completion
2016-11-01
First posted
2016-06-10
Last updated
2025-03-13

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02795286. Inclusion in this directory is not an endorsement.