What this study is
This study will validate the diagnostic accuracy of a cutaneous hydration sensor. This sensor will also be evaluated for its feasibility as a point-of-care device for the assessment of hydration status and its potential to guide hydration therapy in patients with sickle cell disease (SCD).
What's being tested
- Skin Hydration Sensor
Intervention · DEVICE
The device is a skin hydration sensor. The sensor is placed on the skin at the inner arm. It is non-invasive and measures in seconds the percent water content of the dermis by quantifying its dielectric constant.
Study details
- Official title
- Cutaneous Hydration Assessment in Sickle Cell Disease
- Sponsor
- Enrico Novelli
- Conditions
- Sickle Cell Disease
- Enrolling
- 30 people
- Starts
- 2022-01-21
- Est. completion
- 2027-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of Sickle Cell Disease (genotypes SS, SC, Sß-thalassemia, SD, SOArab)
- Participants must be ≥12-years old
- Participants that provide legally effective consent to all study procedures
You can't join if
- Participants under 12-years old
- Participants being treated with experimental therapies in clinical trials
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUPMC Sickle Cell Clinic
Pittsburgh, Pennsylvania, United States
- Enrico Novelli, MD · Contact412-916-3416noveex@upmc.edu
- Manzoor Mohideen, PhD · Contact412-802-8498mohideenm@upmc.edu
- Enrico Novelli, MD · Principal investigator
Recruiting
Study team
Sponsor
Enrico Novelli
Study ID STUDY21090014
Principal investigator
Enrico Novelli, MD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.