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

Deka Research and Development

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: HemoCare™ Hemodialysis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04198012

DKPL-00674-001

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

The HemoCare™ Hemodialysis System

Experimental group

Description:

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.

Treatment:

Device: HemoCare™ Hemodialysis System