Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home… (NCT06613568) | Clinical Trial Compass
RecruitingNot Applicable
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
United States50 participantsStarted 2025-10-06
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1The Moda-flx is being tested both in a professional care setting and at home — what would it actually look like for me to do dialysis at home, and is that something my current health situation and living situation could realistically support?
2This trial is in Phase NA, which suggests it may be evaluating a device rather than a drug — what does that mean for how much is already known about the safety of the Moda-flx system compared to my current or standard dialysis options?
3One of the main things this trial is measuring is 'dialysis adequacy' on a weekly basis — can you explain what that means for my kidney treatment, and how would we know if the Moda-flx is doing its job well enough?
4Since adverse event rate is a primary outcome they're actively tracking, what types of complications or risks are most important for me to understand before considering whether this trial is worth discussing further with you?
5Would starting with this trial make sense given where I am in my treatment right now, or would it be better to try standard hemodialysis options first before considering something being evaluated in a study like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.