NCT03810833

Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System

A Study of Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: MediBeacon · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.

Detailed description

The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102) over time. The device utilized in this study is the Brilliance device. Approximately 1 male and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin Scale groups (I-II \[Light, pale white; white, fair\]; III-IV \[Medium, white to olive; olive, moderate brown\]; and V-VI \[Brown, dark brown; black, very dark brown to black\]) will be recruited, for a total of 12 participants. Participants will have Brilliance device sensors placed on two locations on their skin, which will remain for 48 hours. The sensor location will be prepared through shaving and cleaning (as applicable), placed on the skin via standard single-use adhesive pads, and baseline measurements collected. Participants may undergo activities of daily living while measurements are being collected. Light pressure and other minor perturbations may be applied to the sensors to evaluate the effect on background fluorescence. Adverse events associated with sensor placement (such as skin irritations) will be recorded.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	Brilliance device sensor	Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.

Timeline

• Start date: 2019-09-16
• Primary completion: 2019-09-23
• Completion: 2019-09-23
• First posted: 2019-01-22
• Last updated: 2020-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study