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Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy

NCT05576220 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-03-14

No results posted yet for this study

Summary

IDION is currently seeking FDA approval for this device- the IDION iTempShield. It is a skin-safe, FDA complaint and non-invasive device that can read and monitor skin temperature. Having continuous temperature monitoring using the IDION iTempShield may provide early detection of a fever for patients with febrile neutropenia. Febrile neutropenic fever is common in patients receiving chemotherapy and can often indicate infection. The main potential benefit potenially experienced from participating in this study would be the early detection of fever.

There is a potential benefit that infection will be detected earlier in subjects wearing the IDION iTempShield.

Conditions

Interventions

DEVICE

IDION iTempShield

Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy

Sponsors & Collaborators

  • IDION Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2023-04-30
Completion
2023-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576220 on ClinicalTrials.gov