N/A
N=426
TARGET Post-Approval Study
Complex Regional Pain Syndrome (CRPS)
Bottom Line
View on ClinicalTrials.gov: NCT02800863 ↗Enrolled (actual)
426
Serious AEs
6.1%
Results posted
Jul 2024
Primary outcome: Primary: Rate of Serious Adverse Events (SAEs) — 8.7 percentage of events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) (Device); Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Serious Adverse Events (SAEs) |
8.7 | — |
| SECONDARY Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS) |
44.48 | — |
| SECONDARY Change From Baseline to 12 Months Post-permanent Implant for Physical Function Measured Using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Physical Function Scale |
5.13 | — |
| SECONDARY Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale |
6.22; 4.42 | — |
Summary
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
Eligibility Criteria
Inclusion Criteria
- Subject is male or female between ≥ 22 and ≤ 75 years of age.
- Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
- Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment.
- Subject is willing and able to comply with the study requirements.
- Subject is able to provide written informed consent.
Exclusion Criteria
- Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
- Subject is currently involved in medically related litigation, including workers compensation.
- Subject has a life expectancy of less than one year.
- Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
- Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
- Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
- Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.
Data sourced from ClinicalTrials.gov (NCT02800863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.