NCT04868643

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

A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the DIMI Renal Replacement Therapy (RRT) System In-Center by Trained Dialysis Nurses and In-Home by Trained Care Partners and Patients With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dialco Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study phases, according to the schedule outlined below. The schedule will consist of four phases and the number of sessions per week will be prescribed the same throughout Phase 1 to 4.

Detailed description

1. Phase 1: Run-in. Duration: 2 weeks. Potential Subjects will undergo dialysis treatments 3 - 5 times per week for up to 2 weeks In-Center. Treatments will be administered by study staff during this phase. Study eligibility will be assessed for both the potential Subject and their Care Partner after completion of the run-in period. Potential subjects and Care Partners who meet all eligibility criteria will be invited to Phase 2. 2. Phase 2: In-Center Treatment. Duration: 6 weeks. Subjects will undergo dialysis treatments 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) In-Center. Treatments will be administered by study staff. 3. Phase 3: Cross-over Period from In-Center to In-Home environment. Duration: 4 weeks. Care Partners will undergo the DIMI training, then perform dialysis treatments on Subjects 3 - 5 times per week for approximately 4 weeks (for a total of 12 - 20 sessions). Treatments will be completed In-Center under the supervision of hemodialysis nurses and at the discretion of the investigator. 4. Phase 4: In-Home Treatment. Duration: 6 weeks. Care Partners will perform dialysis treatments to the Subject 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) in a home environment.

Conditions

• ESRD
• Hemodialysis

Interventions

Type	Name	Description
DEVICE	The DIMI Renal Replacement Therapy (RRT) System	To demonstrate that the safety and efficacy of the DIMI RRT remains consistent when used In-Center by trained dialysis nurses versus in an In-Home environment by trained Care Partners and Subjects.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-08-01
• Completion: 2026-08-01
• First posted: 2021-05-03
• Last updated: 2024-03-22

Regulatory

• FDA-regulated device study