Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System

NCT ID: NCT03810833

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2019-09-23

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Participants with Brilliance sensor placement

Brilliance device sensors placed on the left and right pectoralis major, remaining for 48 hours

Group Type: EXPERIMENTAL

Brilliance device sensor

Intervention Type: DEVICE

Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy male and female adults age 18 and older
• 2 age cohorts to be recruited: 18 - 50 years of age and 51+ years or older
• Skin color groups to be recruited in accordance with the Fitzpatrick Skin Scale (I - VI)
• Participants willing to sign the Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study specific procedures.

Exclusion Criteria

• History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
• Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
• Significant scarring, tattoos or alterations in pigmentation on the standardized sensor locations that would alter sensor readings versus other areas of the skin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MediBeacon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard B Dorshow, PhD

Role: STUDY_DIRECTOR

MediBeacon

Locations

St. Louis Clinical Trials

St Louis, Missouri, United States

Countries

United States

Other Identifiers

ORFM Sensor 100-01

Identifier Type: -

Identifier Source: org_study_id