Self-care training using the Tablo hemodialysis system.

INTRODUCTION: Recently published results of the investigational device exemption (IDE) trial using the Tablo hemodialysis system confirmed its safety and efficacy for home dialysis. This manuscript reports additional data from the Tablo IDE study on the training time required to be competent in self-care, the degree of dependence on health care workers and caregivers after training was complete, and participants' assessment of the ease-of-use of Tablo. METHODS: We collected data on the time required to set up concentrates and the Tablo cartridge prior to treatment initiation. We asked participants to rate system setup, treatment, and takedown on a Likert scale from 1 (very difficult) to 5 (very simple) and if they had required any assistance with any aspect of treatment over the prior 7 days. In a subgroup of 15 participants, we recorded the number of training sessions required to be deemed competent to do self-care dialysis. FINDINGS: Eighteen men and 10 women with a mean age of 52.6 years completed the study. Thirteen had previous self-care experience using a different dialysis system. Mean set up times for the concentrates and cartridge were 1.1 and 10.0 minutes, respectively. Participants with or without previous self-care experience had similar set-up times. The mean ease-of-use score was 4.5 or higher on a scale from 1 to 5 during the in-home phase. Sixty-five percent required no assistance at home and on average required fewer than four training sessions to be competent in managing their treatments. Results were similar for participants with or without previous self-care experience. CONCLUSIONS: Participants in the Tablo IDE trial were able to quickly learn and manage hemodialysis treatments in the home, found Tablo easy to use, and were generally independent in performing hemodialysis.

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

INTRODUCTION: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. METHODS: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data. FINDINGS: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. CONCLUSION: Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.