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| General |
| Study Status |
Other |
| 522 Number / Requirement Number |
PS200007 / PSS001 |
| Date Original Plan Accepted |
03/05/2021
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| Date Current Plan Accepted |
02/04/2022
|
| Study Name |
Human Factors Study
|
| Device Name |
Tablo hemodialysis system
|
| Root Document Number |
K200741
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a post-market human factors validation study of the Tablo Hemodialysis System in participants with end stage renal disease in the home setting. The study is designed to include both a simulated-use human factors study and a prospective, multi-center actual-use human factors study. This is a new enrollment study. To supplement the human factors study, the post-market study will also include an adverse events and complaints analysis for all home users of the device (including for participants in the actual-use study).
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| Study Population |
The simulated-use study population will be hemodialysis patients and their care partners who are representative home-users.
The actual-use study will enroll participants who plan to start home hemodialysis with the Tablo System. Participants must meet all eligibility criteria and provide written informed consent prior to conducting any study specific procedures not considered standard of care.
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| Sample Size |
The simulated-use study will have a sample size of at least 15 participants (15 each of patient and their care partner).
The actual-use study will have a minimum of 15 participants (patients and their care partners).
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| Key Study Endpoints |
The study endpoints for the actual-use study are:
- Evaluation of use-related performance on critical tasks (including successes, use errors, close calls,
difficulties, and observational use experience).
- Evaluation and analysis of root-cause for any use-related errors, close calls, and difficulties.
- Evaluation of participant comprehension using the Warnings and Cautions Knowledge Tests.
- Descriptive summary of participant demographics (e.g., age, sex, vascular access) compared to
real-world intended users.
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| Follow-up Visits and Length of Follow-up |
The length of follow-up for the actual-use study is 2 months.
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