Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
VitalTraq for the Detection of CRS
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients body temperature VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None