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NCT06415656 · ClinicalTrials.gov registry record · NA

VitalTraq for the Detection of CRS

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
32
Enrollment target

NCT06415656: Completed NA study, sponsored by Duke University.

NCT06415656 is a NA study that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06415656, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target

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.

Primary Outcome

Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).

Interventions

  • DEVICE TempTraq
  • DEVICE VitalTraq

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2024-10-13
Est. Completion 2025-07-07
Phase NA
Duke University

1,725 total trials

What the finished NCT06415656 record still lists

NCT06415656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which TempTraq is the first listed.

NCT06415656 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06415656 about?

NCT06415656 is a clinical study titled "VitalTraq for the Detection of CRS". 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 ...

What is the current status of trial NCT06415656?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2024-10-13. Estimated completion is 2025-07-07.

What interventions are being tested in trial NCT06415656?

The interventions under investigation include: TempTraq (DEVICE), VitalTraq (DEVICE).

Who is sponsoring clinical trial NCT06415656?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06415656's enrollment target sits among peer trials

32 1578th of 2000 higher than 409 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06415656, the US trial registry maintained by the National Library of Medicine. NCT06415656 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.