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Trial Title:
VitalTraq for the Detection of CRS
NCT ID:
NCT06415656
Condition:
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
TempTraq
Description:
TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable,
wireless temperature monitoring patch designed to continuously monitor and track body
temperature.
Arm group label:
Patients with hematologic malignancies
Intervention type:
Device
Intervention name:
VitalTraq
Description:
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.
Arm group label:
Patients with hematologic malignancies
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke Blood Cancer Center
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Hill
Phone:
919-668-2369
Email:
lauren.hill@duke.edu
Investigator:
Last name:
Chenyu Lin, MD
Email:
Principal Investigator
Start date:
October 13, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Blue Spark Technologies
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415656
