The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment

Korábbi kezelés

• Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite medical therapy.
• Subject has uncontrolled blood pressure (e.g. sustained/persistent pre- dialysis systolic blood pressure greater than 180 mmHg despite maximal medical therapy in two of the last three treatments).
• Subject is participating in another investigative drug or device clinical study related to Home Hemodialysis which conflicts with the execution of this study.
• Subject is expected to receive a kidney transplant from any donor organ in the next 6 months.
• Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.

Más betegség

• Subject has dementia or lacks capacity for self-care.
• Subject has a documented history of non-adherence to dialysis treatment that would prevent successful completion of the study.
• Subject has an active infection requiring antibiotics within the last 7 days.
• Subject is seroreactive for Hepatitis B Surface Antigen.
• Subject has an active, life-threatening, rheumatologic disease.
• Subject has a history of adverse reactions to dialyzer membrane material.
• Any other condition that the Investigator feels would prevent the Subject from being a suitable candidate for inclusion in the study.

Laborértékek

• Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.

Egyéb

• Life expectancy less than 12 months from first study procedure.
• Subject is unable to understand or cooperate with hemodialysis nurse and dialysis care team.
• Subject has had a recent major cardiovascular adverse event within the last 3 months.
• Subject has symptomatic intra-dialytic hypotension requiring medical intervention in two of their last three treatments.
• Subject has fluid overload due to intractable ascites secondary to liver cirrhosis.
• Subject is intolerant to heparin.

• Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
• Subject is at least 18 years and less than 75 years of age.
• Subject has identified an individual "Care Partner" to be trained and available as needed. Such Care Partner must be considered competent to train on the use of the device by the prescribing physician, and must commit to the trial.
• Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
• Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
• Subject has a documented psychosocial evaluation by a qualified social worker, treating physician or home hemodialysis nurse.
• Subject has no childbearing potential or has a negative pregnancy test within 7 days prior to the start of the first study treatment and will be utilizing medically acceptable means of contraception during the study period.
• Subject has a home environment to perform hemodialysis that meets the criteria of Home Use Environment (defined in Section 15.1).