Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT03452020
Status:
UNKNOWN
Last Update Posted:
2018-03-02
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
Sponsor:
Tyto Care Ltd
Organization:
Study Overview
Official Title:
Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
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:
Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.
The patients will be divided into 3 study groups by age:
Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years
The following temperature measurements will be taken:
1. Three temperature measurements using the Tyto thermometer
2. Temperature measurement using the standard of care
3. Three temperature measurements using the predicate device
The patients will be divided into 3 study groups by age:
Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years
The following temperature measurements will be taken:
1. Three temperature measurements using the Tyto thermometer
2. Temperature measurement using the standard of care
3. Three temperature measurements using the predicate device
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?: