Carry Life® UF system clinical study
Research type
Research Study
Full title
A clinical study with the Carry Life® UF system in continuous ambulatory peritoneal dialysis (CAPD) patients
IRAS ID
327180
Contact name
Stanley Fan
Contact email
Sponsor organisation
Triomed AB
Clinicaltrials.gov Identifier
CIV-23-03-042555, EUDAMED number
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Chronic kidney disease (CKD) poses a high economic burden for health care systems and to individuals affected by the disease. The causes of CKD are many and can be due to age related decline of renal function compounded by hypertension, diabetes, and primary renal disorders. The global prevalence of CKD is estimated to be between 11-13%.
CKD can progress to end-stage kidney disease where dialysis therapy or a kidney transplant is required.The study device, the Carry Life® UF system, is for peritoneal dialysis (PD) and ultrafiltration (UF). The therapeutic concept of the Carry Life® UF system is to maintain a stable intraperitoneal (IP) glucose concentration and thereby achieving a stable peritoneal UF. The Carry Life® UF system is indicated for PD and UF in adult patients with end-stage kidney disease (ESKD). Treatment with the Carry Life® UF system is prescribed by the treating physician and intended for use in dialysis clinics or in the home environment.
The Carry Life® UF system aims to provide an effective management of fluid overload which is associated with increased mortality, hospitalization and technique failure.
The primary aim of the study is to demonstrate that a 5-hour Carry Life® UF treatment at home results in an increased ultrafiltration (UF) volume compared to a 5-hour treatment with the standard therapy (2.27% glucose CAPD dwell in adult CAPD patients).
This study is a pre-market, prospective, multicenter, randomized, crossover study and 25 patients from up 8 European sites will participate in this clinical investigation.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0138
Date of REC Opinion
22 Jun 2023
REC opinion
Further Information Favourable Opinion