|
|
| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P150004 / PAS001 |
| Date Original Protocol Accepted |
05/26/2016
|
| Date Current Protocol Accepted |
08/05/2021
|
| Study Name |
F/U Axium Neurostimulator System (FANS)
|
| Device Name |
Axium Neurostimulator System
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The “FANS PAS” is a prospective, multicenter, single arm, observational post-approval study to be conducted at up to 45 centers in the United States in order to demonstrate continued safety and effectiveness of the “Axium Neurostimulator System” or the “Proclaim DRG Neurostimulator System”. The primary objective of the “FANS PAS” is to demonstrate that the proportion of serious adverse events (SAEs) at 12 months for subjects who receive a permanent implant is lower than a pre- specified performance goal. Secondary objectives of the “FANS PAS” are to evaluate change in overall pain intensity, change in physical function and change in quality of life over the study period.
|
| Study Population |
A maximum of 426 adult subjects with moderate to severe chronic, intractable pain of the lower limbs due to CRPS types I and II will undergo a trial of the neurostimulator system at up to 45 study sites in the United States.
Inclusion Criteria:
Male or female between the ages of 22 and 75 years.
Moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
Baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment.
Willing and able to comply with the study requirements.
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 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.
|
| Sample Size |
The primary objective of this study is to demonstrate that the proportion of serious adverse events for subjects who receive a permanent Axium or Proclaim DRG IPG is lower than a pre-specified performance goal. The primary endpoint is the 12-month serious adverse event rate for subjects receiving an Axium or Proclaim DRG IPG permanent implant. The performance goal is based on the 12- month serious adverse event rate for Axium subjects in the ACCURATE IDE study, where the observed rate was 10.5%. A non-inferiority margin of 5% is assumed. A total of 8 out of 76 (10.5%) subjects experienced a serious adverse event in the ACCURATE IDE study.
The sample size required to reject the null hypothesis for the primary endpoint at the 5% significance level with 80% power assuming a 12-month serious adverse event rate of 10.5% is 287 subjects receiving the permanent Axium or Proclaim DRG IPG. Assuming an attrition rate of 25% from trial to permanent Axium or Proclaim DRG IPG implant, and an attrition rate of 10% from permanent implant to 12-month follow-up, a total of 426 (=287/0.9/0.75) subjects will be implanted with a trial system. The target number of subjects for permanent Axium or Proclaim DRG IPG implants is 319, and the target number of subjects for the primary endpoint analysis is 287.
|
| Key Study Endpoints |
Primary Endpoint
The primary endpoint is the 12-month SAE rate for subjects receiving the permanent DRG IPG.
Secondary Endpoints
Percent change from baseline to 12 months post-permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS)
Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS-29 Profile
Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale
Descriptive Endpoints
Safety
Proportion of subjects with device, procedure or stimulation related SAEs and non-SAEs among subjects who receive the permanent implant
Proportion of subjects who have AEs related to the trial implant procedure among subjects who fail the trial neurostimulator phase
Summary of procedure-related SAEs and non-SAEs by implanter experience
Effectiveness
Change from baseline to 1, 3, and 6 months post permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS)
Change from baseline to 1, 3, and 6 months post permanent implant for physical function measured using the PROMIS-29 Profile
Change from baseline to 1, 3, and 6 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale
Change from baseline to 1, 3, 6 and 12 months post-permanent implant for neuropathic pain measured using the Neuropathic Pain Scale (NPS)
Change from baseline to 1, 3, 6 and 12 months post-permanent implant for sleep disturbance, anxiety, depression, fatigue, ability to participate in social roles and activities, pain
interference and pain intensity measured using the PROMIS-29 Profile
Patient Global Impression of Change (PGIC) at 1, 3, 6 and 12 months post-permanent implant
Additional Data
All descriptive endpoints above will be examined at 18 and 24 months for all subjects with evaluable data for those study visits. Additional data, including but not limited to, percentage of subjects achieving at least a 30% and 50% pain reduction, demographics, paresthesia coverage and intensity, subject satisfaction, programming parameters, implant procedure information, and system information may be compiled.
|
| Follow-up Visits and Length of Follow-up |
up to 24 months
|
|
