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VitalTraq for the Detection of CRS

NCT06415656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-07-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

Conditions

  • Hematologic Malignancy

Interventions

DEVICE

TempTraq

TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.

DEVICE

VitalTraq

VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.

Sponsors & Collaborators

Principal Investigators

  • Chenyu Lin, MD · Duke University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-13
Primary Completion
2025-06-15
Completion
2025-07-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06415656 on ClinicalTrials.gov