NCT02772146

A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Triomed AB · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.

Conditions

• Heart Failure
• Cardio-Renal Syndrome

Interventions

Type	Name	Description
DEVICE	CLS UF	One single ultrafiltration session of 10 hours.

Timeline

• Start date: 2016-05-11
• Primary completion: 2017-01-23
• Completion: 2017-01-23
• First posted: 2016-05-13
• Last updated: 2017-03-14

Locations

1 site across 1 country: Germany