Skin Hydration Sensor for Anemia, Sickle Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anemia, Sickle Cell+1 More
Skin Hydration Sensor - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Anemia, Sickle Cell

Treatment Effectiveness

Study Objectives

19 Primary · 0 Secondary · Reporting Duration: At a regularly scheduled clinical appointment, approximately 2 hours

Hour 2
Clinical dehydration assessments in SCD participants
Measurement of elongation index as a cellular biomarker of dehydration in SCD participants
Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants
Measurement of point of sickling as a biomarker of dehydration in SCD participants
Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants
Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants
Hour 2
Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE
Hour 2
Dehydration
Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Hour 2
Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE
Hour 2
Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
Hour 2
Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE
Hour 2
Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE
Hour 2
Dermal water content measurements in SCD participants at baseline state of health

Trial Safety

Trial Design

1 Treatment Group

Skin Hydration Sensor
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Skin Hydration Sensor · No Placebo Group · N/A

Skin Hydration Sensor
Device
Experimental Group · 1 Intervention: Skin Hydration Sensor · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at a regularly scheduled clinical appointment, approximately 2 hours

Who is running the clinical trial?

Enrico M NovelliLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Anemia, Sickle Cell
20 Patients Enrolled for Anemia, Sickle Cell
Enrico Novelli, MDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Anemia, Sickle Cell
200 Patients Enrolled for Anemia, Sickle Cell

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 12 years old or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.