Status:
COMPLETED
Prometra Post-Approval Study
Lead Sponsor:
Flowonix Medical
Conditions:
Chronic Pain
Cancer Pain
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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.
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
June 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01854229
Start Date
June 20 2013
End Date
March 15 2023
Last Update
October 18 2023
Active Locations (26)
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1
Perlman Clinic
La Jolla, California, United States, 92037
2
Pacific Pain Physicians
Santa Barbara, California, United States, 93105
3
Evolve Restorative Center
Santa Barbara, California, United States, 95403
4
Summit Pain Alliance
Santa Rosa, California, United States, 95401