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Skin Hydration Sensor for Sickle Cell Disease
N/A
Recruiting
Led By Enrico Novelli, MD
Research Sponsored by Enrico M Novelli
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Sickle Cell Disease (genotypes SS, SC, Sß-thalassemia, SD, SOArab)
Participants must be ≥12-years old
Must not have
Participants under 12-years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at a regularly scheduled clinical appointment, approximately 2 hours
Awards & highlights
Summary
This trial will test a new sensor to see if it can accurately measure hydration levels in patients with sickle cell disease. The sensor could be used to help guide hydration therapy for these patients.
Who is the study for?
This trial is for individuals aged 12 or older who have been diagnosed with Sickle Cell Disease, including various genotypes like SS, SC, and others. Participants must be able to give legal consent to all study procedures. Those under 12 or currently in other clinical trials for experimental therapies cannot join.Check my eligibility
What is being tested?
The trial is testing a new skin hydration sensor designed to accurately assess hydration levels in patients with Sickle Cell Disease. The goal is to see if this sensor can work as an easy-to-use device at the point of care and help guide proper hydration therapy.See study design
What are the potential side effects?
Since the intervention involves a non-invasive skin hydration sensor, there are no direct side effects expected from its use. However, any discomfort or issues related to wearing the device will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Sickle Cell Disease.
Select...
I am 12 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 12 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at a regularly scheduled clinical appointment, approximately 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at a regularly scheduled clinical appointment, approximately 2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical dehydration assessments in SCD participants
Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE
Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE
+16 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Skin Hydration SensorExperimental Treatment1 Intervention
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Who is running the clinical trial?
Enrico M NovelliLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Enrico Novelli, MDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
226 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Sickle Cell Disease.I am 12 years old or older.I am under 12 years old.You are currently participating in another clinical trial testing an experimental treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Skin Hydration Sensor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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