CompletedNot Applicable

Prometra Post-Approval Study

United States400 participantsStarted 2013-06-20

Plain-language summary

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

Who can participate

Age range

22 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.

Inclusion criteria

. Patient meets at least one of the following:
. Patient is at least 22 years of age.
. Investigator considers the patient to be able and willing to fulfill all study requirements.
. Patient has provided written informed consent to participate in the study.

Exclusion criteria

. Patient meets any of the contraindications for use of the Prometra System
. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Rate of granuloma formation

Timeframe: Five years

Trial details

NCT IDNCT01854229

SponsorFlowonix Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-15

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