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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06415656
Other study ID # Pro00115012
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Duke University
Contact Lauren Hill
Phone 7045774113
Email lauren9494@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Duke University Blue Spark Technologies

Outcome

Type Measure Description Time frame Safety issue
Primary TempTraq's ability to measure axillary temperature in the intended use population. Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Day 14
Secondary Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements. The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature > 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers. Day 14
Secondary VitalTraq's ability to measure blood pressure in the intended use population. Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively. Day 14
Secondary VitalTraq's ability to measure heart rate in the intended use population. Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute. Day 14
Secondary Patient's perspective on the burden of using TempTraq and VitalTraq. The mean scores on individual questions in a post-intervention survey featuring 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree, will be calculated and described. A lower score indicates lower burden. Day 28
Secondary Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care. The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring. Day 14
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