NCT04655989

A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System

A Prospective, Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System in Adult Patients With Chronic Renal Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Nikkiso America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.

Detailed description

The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion. The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control). The study population will include eligible adult patients diagnosed with chronic renal failure requiring routine dialysis treatments for a minimum of 90 days and with a minimum of 3 weekly sessions. Treatment duration will be at the discretion of the investigator. The duration of study participation for each subject is approximately eight (8) weeks; four (4) weeks of routine dialysis and four (4) weeks of treatment dialysis. The expected total study duration across all subjects (from recruitment to last subject visits) is approximately five (5) to six (6) months, dependent upon subject recruitment/enrollment and meeting 360 evaluable treatments. A minimum of 30 eligible subjects will be enrolled into the study ensuring a minimum of 360 evaluable treatments in the treatment arm. The sub-study, VARRM, was conducted following the subject's completion of the primary eight (8) week clinical study. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Subjects that participated in the VARRM sub-study had their vascular recirculation rates collected during treatments. A minimum of 12 subjects were expected to participate in this sub-study, with a minimum of 21 and maximum of 36 dialysis accesses evaluated.

Conditions

• Dialysis
• Chronic Renal Failure

Interventions

Type	Name	Description
DEVICE	DBB-EXA ES Hemodialysis System	The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-02-24
• Completion: 2021-05-01
• First posted: 2020-12-07
• Last updated: 2021-10-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study