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| General |
| Study Status |
Hold |
Application Number /
Requirement Number |
H190001 / PAS001 |
| Date Original Protocol Accepted |
10/04/2021
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| Date Current Protocol Accepted |
10/16/2023
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| Study Name |
HALO-FHII PAS
|
| Device Name |
Plasma Delipidation System (PDS-2™ System)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objectives of the summative usability evaluation are to:
1. Demonstrate that the device can be used by representative intended users under simulated and actual use conditions, without producing patterns of failures that could result in a negative clinical impact to patients or harm to users or patients;
2. Demonstrate that the device design, representative training and labeling are effective in mitigating all use-related risks to an acceptable level;
3. Demonstrate that no new use-related hazards or hazardous scenarios have emerged, and evidence supports that benefits outweigh the residual use-related risks; and
4. Demonstrate that operators are able to prepare the solvent mixture correctly, including verification of the mixture
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| Study Population |
1. Age: 18+ years old
2. Gender: Male or Female
3. Education: Undergraduate degree
4. Experience: unrestricted
5. Primary Duties: Performs laboratory procedures, including preparing and testing specimens and recording results
6. Training: on-the-job instrument training, aseptic technique, blood/plasma handling procedure
7. Hearing: unrestricted
8. Vision: corrected vision or no impairments
9. Permissible impairments: appropriate to the job
10. Language: English
11. Cultural Background: unrestricted
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| Sample Size |
The sample will consist of trained HDL Therapeutics professionals, N=5.
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| Key Study Endpoints |
The summative usability study data collection and analysis is intended to provide sufficient and appropriate data to facilitate identification and understanding of the root causes of any use failures or problems that occur, including usability issues. The root cause analysis is intended to identify causes that are related to the design of the system, the system labeling (including IFU), and the training of test participants. Only the completion of the task without any observed use difficulties, use errors, or assistance from the moderator will be deemed a successful outcome. All other outcomes will be considered degrees of failure for which the moderator will observe and report the nature of the issues in greater detail. A failure can be classified as any assistance provided by the moderator to a test participant for any specific task, beyond what is provided during the training session. A failure can also result if the participant performs a task incorrectly and does not request help. The acceptable range for the number of attempts for this system is three. There will be a limit of 3 times a participant can attempt a task.
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| Follow-up Visits and Length of Follow-up |
The follow-up will be immediately after the 8 hour training evaluation.
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