Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Flowonix Medical
This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patient meets at least one of the following:
* is suffering from malignant pain (i.e., cancer pain)
* has chronic, non-malignant pain
* subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
* Patient with an existing implantable pump for pain therapy that requires replacement
2. Patient is at least 22 years of age.
3. Investigator considers the patient to be able and willing to fulfill all study requirements.
4. Patient has provided written informed consent to participate in the study.
You may not be if
1. Patient meets any of the contraindications for use of the Prometra System
2. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
3. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
