NCT04198012

An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System

An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Deka Research and Development · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	HemoCare™ Hemodialysis System	The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.

Timeline

• Start date: 2019-12-16
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2019-12-13
• Last updated: 2025-09-08
• Results posted: 2025-09-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study