VitalTraq for the Detection of CRS

NCT ID: NCT06415656

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-13
• Study Completion Date: 2025-07-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with hematologic malignancies

Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.

Group Type: EXPERIMENTAL

TempTraq

Intervention Type: DEVICE

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

VitalTraq

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows:

• Axicabtagene ciloleucel
• Lisocabtagene maraleucel
• Brexucabtagene autoleucel
• Idecabtagene vicleucel
• Ciltacabtagene autoleucel
• Obecabtagene autoleucel
• Tisagenlecleucel
• Blinatumomab
• Mosunetuzumab
• Talquetamab
• Elranatamab
• Teclistamab
• Glofitamab

2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening.

3. Able to read and understand English

4. Willing and able to provide informed consent to the study

Exclusion Criteria

1. Receiving a non-FDA approved CAR-T or BiTE product

2. Receiving Epcoritamab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blue Spark Technologies

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chenyu Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Blood Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00115012

Identifier Type: -

Identifier Source: org_study_id