Recruiting

Observational Study

Sponsor:

Enrico Novelli

Code:

NCT05210114

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Skin Hydration Sensor

Study Details

Brief summary:

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).

Conditions

Sickle Cell Disease

Study ID

NCT05210114

Start date

Jan 21, 2022

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Participants under 12-years old
  • Participants being treated with experimental therapies in clinical trials

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Skin Hydration Sensor

Interventions

Skin Hydration Sensor

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.

Primary outcome measure

  • Dermal water content measurements in SCD participants at baseline state of health [ Time Frame: During a regularly scheduled clinic appointment, approximately 2 hours ]
  • Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event before IV fluid resuscitation, approximately 2 hours ]
  • Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event after IV fluid resuscitation, approximately 2 hours ]
  • Clinical dehydration assessments in SCD participants [ Time Frame: At a regularly scheduled clinical appointment, approximately 2 hours ]
  • Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants [ Time Frame: At a regularly scheduled clinical appointment, approximately 2 hours ]
  • Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants [ Time Frame: At a regularly scheduled clinical appointment, approximately 2 hours ]
  • Measurement of elongation index as a cellular biomarker of dehydration in SCD participants [ Time Frame: At a regularly scheduled clinical appointment, approximately 2 hours ]
  • Measurement of point of sickling as a biomarker of dehydration in SCD participants [ Time Frame: At a regularly scheduled clinical appointment, approximately 2 hours ]
  • Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants [ Time Frame: At a regularly scheduled clinical appointment, approximately 2 hours ]
  • Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event before resuscitation therapy, approximately 2 hours ]
  • Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event before fluid resuscitation, approximately 2 hours ]
  • Measurement of elongation index as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours ]
  • Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [ Time Frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours ]

Central Contacts and Locations

Central contacts

Enrico Novelli, MD

412-916-3416noveex@upmc.edu

Manzoor Mohideen, PhD

412-802-8498mohideenm@upmc.edu

Locations

UPMC Sickle Cell Clinic

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Enrico Novelli, MD

412-916-3416noveex@upmc.edu

Manzoor Mohideen, PhD

412-802-8498mohideenm@upmc.edu

Principal Investigator:

Enrico Novelli, MD

More Information

Sponsor

Enrico Novelli

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Enrico Novelli on 2025-11-12.