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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
University of Mississippi Medical Center
Jackson, Mississippi, United States
DCI North Brunswick
North Brunswick, New Jersey, United States
The Rogosin Institute
New York, New York, United States
Dialysis Clinic, Inc.
Knoxville, Tennessee, United States
Number of Subjects With Safety Event
The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.
Time frame: 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dialysis Clinic, Inc.
Nashville, Tennessee, United States
Wellbound South Austin
Austin, Texas, United States
Wellbound North Austin
Austin, Texas, United States