Status:
COMPLETED
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
Lead Sponsor:
MediBeacon
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18-99 years
Phase:
NA
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 monito...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03810833
Start Date
September 16 2019
End Date
September 23 2019
Last Update
January 10 2020
Active Locations (1)
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1
St. Louis Clinical Trials
St Louis, Missouri, United States, 63141