Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT03835260
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2019-02-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivot Breath Sensor Human Factors and Usability Study
Sponsor:
Jennifer Marler, MD
Organization:
Study Overview
Official Title:
Pivot Breath Sensor Human Factors and Usability Study
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.
Detailed Description:
The objectives of this Human Factors/Usability study are to:
* Ensure that representative intended users are able to operate the Pivot Breath Sensor independently
* Validate appropriate mitigations of use related hazards identified in risk management documentation
* Uncover previously unforeseen use errors
This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.
* Ensure that representative intended users are able to operate the Pivot Breath Sensor independently
* Validate appropriate mitigations of use related hazards identified in risk management documentation
* Uncover previously unforeseen use errors
This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: