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 range22 Years

SexALL

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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.

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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