Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System

NCT03810833 | Completed FDA Device

• 1 other identifier: ORFM Sensor 100-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

• Mean Background Fluorescence

  Two separate Brilliance device sensors will be attached via standard adhesive pads to the left and right pectoralis major on each participant. Fluorescence measurements will be collected directly by the MediBeacon Transdermal GFR Measurement System Brilliance device, and will be continuously collected throughout the 48 hour study.

  From the time of sensor placement to 48 hours after placement

Study Arms (1)

Participants with Brilliance sensor placement

EXPERIMENTAL

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

Device: Brilliance device sensor

Interventions

Brilliance device sensor DEVICE

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

Participants with Brilliance sensor placement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female adults age 18 and older
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MediBeacon: lead

Study Sites (1)

St. Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Richard B Dorshow, PhD

  MediBeacon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: September 16, 2019
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)