Prometra Post-Approval Study

Not Applicable

Completed

• Conditions: Chronic Pain; Back Pain; Cancer Pain; Intractable Pain

• Registration Number: NCT01854229
• Lead Sponsor: Flowonix Medical

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 in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Study Start: 2013-06-20
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of granuloma formation	Five years	The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.

Secondary Outcome Measures

Name	Time	Method
Pump battery life	Five years	Tabulation of occurences of premature pump battery depletions
Pump failure	Five years	Tabulation of pump failures, including time to occurrence and type

Trial Locations

Locations (26)

Perlman Clinic; 🇺🇸 La Jolla, California, United States

Pacific Pain Physicians; 🇺🇸 Santa Barbara, California, United States

Evolve Restorative Center; 🇺🇸 Santa Barbara, California, United States

Summit Pain Alliance; 🇺🇸 Santa Rosa, California, United States

BioHealth Pain Management; 🇺🇸 Torrance, California, United States

Interventional Pain Management; 🇺🇸 Daytona Beach, Florida, United States

Florida Institute of Medical Research; 🇺🇸 Jacksonville, Florida, United States

Palm Beach Pain Management; 🇺🇸 Lake Worth, Florida, United States

Pain Institute of Tampa; 🇺🇸 Tampa, Florida, United States

Global Scientific Innovations; 🇺🇸 Evansville, Indiana, United States

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