End Stage Renal Disease
Conditions
Keywords
HemoCare™ Hemodialysis System, HemoCare™, Hemodialysis
Brief 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.
Interventions
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.
Sponsors
Deka Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label rollover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator. * Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System. * Have a trained study care partner able to support subject for all at-home study treatments. * Subject and care partner can read and understand English and provide written informed consent. * Have a stable functioning vascular access as judged by the treating physician.
Exclusion criteria
* Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study. * Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study. * Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures. * Are participating or planning to participate in any other interventional studies except DKPL-00057-001.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Safety Event | 52 weeks | The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The HemoCare™ Hemodialysis System All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | The HemoCare™ Hemodialysis System |
|---|---|
| Age, Continuous | 48.24 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 22 / 25 |
| serious Total, serious adverse events | 15 / 25 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| The HemoCare™ Hemodialysis System | Number of Subjects With Safety Event | Device-Related Adverse Event | 5 participants |
| The HemoCare™ Hemodialysis System | Number of Subjects With Safety Event | Anticipated Serious Adverse Event | 6 participants |
| The HemoCare™ Hemodialysis System | Number of Subjects With Safety Event | Device Related Serious Adverse Event | 0 participants |
| The HemoCare™ Hemodialysis System | Number of Subjects With Safety Event | Anticipated Adverse Event | 20 participants |
| The HemoCare™ Hemodialysis System | Number of Subjects With Safety Event | Unanticipated Adverse Event | 20 participants |
| The HemoCare™ Hemodialysis System | Number of Subjects With Safety Event | Unanticipated Serious Adverse Event | 12 participants |