NCT05381961

Observational Study of BIS in Hemodialysis Patients

Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: ImpediMed Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.

Detailed description

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.

Conditions

• Kidney Failure, Chronic
• Renal Failure Chronic
• Hemodialysis

Interventions

Type	Name	Description
DEVICE	Bioimpedance spectroscopy (BIS) measurement, SOZO device	All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.

Timeline

• Start date: 2022-04-04
• Primary completion: 2022-11-08
• Completion: 2023-09-01
• First posted: 2022-05-19
• Last updated: 2023-09-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study