Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03835260
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.
Study:
NCT03835260
Study Brief:
Protocol Section:
NCT03835260