Trial Outcomes & Findings for TARGET Post-Approval Study (NCT NCT02800863)
NCT ID: NCT02800863
Last Updated: 2024-07-08
Results Overview
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
COMPLETED
426 participants
throughout 12 month study
2024-07-08
Participant Flow
The study enrolled a total of 426 subjects at 44 investigational sites. The first subject was enrolled in August 2016 and the last subject in December 2019. Completion of enrollment and follow-up in the study occurred in September 2021.
Participant milestones
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Overall Study
STARTED
|
426
|
|
Overall Study
COMPLETED
|
198
|
|
Overall Study
NOT COMPLETED
|
228
|
Reasons for withdrawal
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Another Device Implanted
|
1
|
|
Overall Study
Device Explanted
|
1
|
|
Overall Study
Device Has Been Turned Off Since Jan 2019
|
1
|
|
Overall Study
Health Issues
|
1
|
|
Overall Study
Insurance Denial
|
8
|
|
Overall Study
No Perm Implant, Active Pain Pump Implanted
|
1
|
|
Overall Study
Patient Did not Obtain at Least 50% Pain Relief
|
1
|
|
Overall Study
Screen Failure
|
1
|
|
Overall Study
Sponsor Request
|
6
|
|
Overall Study
Death
|
3
|
|
Overall Study
Subject Implant at Another Facility
|
1
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Subject Participation Terminated by Investigator
|
17
|
|
Overall Study
Subject and/or Family Request
|
64
|
|
Overall Study
Trial Failure
|
81
|
|
Overall Study
Used Different Battery not Approved for Study at Time of Perm
|
1
|
Baseline Characteristics
TARGET Post-Approval Study
Baseline characteristics by cohort
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=426 Participants
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
375 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
361 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
426 participants
n=5 Participants
|
|
Complex Regional Pain Syndrome (CRPS)
CRPS I
|
301 Participants
n=5 Participants
|
|
Complex Regional Pain Syndrome (CRPS)
CRPS II
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: throughout 12 month studyPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
Outcome measures
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=296 Participants
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Rate of Serious Adverse Events (SAEs)
|
8.7 percentage of events
Standard Error 1.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The VAS is a common, self-administered measure in which subjects rate their pain intensity by marking a vertical line through a 100 mm horizontal line anchored by word descriptors on each end (no pain to worst imaginable pain). The distance between the beginning of the horizontal line and the vertical line is measured to produce a score between 0 and 100 mm (or 0 to 10 cm). A higher score indicates higher pain intensity and a 30% reduction in VAS score from baseline to follow-up is considered clinically relevant.
Outcome measures
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=213 Participants
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)
|
44.48 percent
Standard Deviation 34.15
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The PROMIS-29 Profile is an instrument made up of seven individual short forms (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference) that are scored individually. The instrument also includes a single pain intensity item which is reported as its raw score (e.g., 0 to 10). Each item has five response options ranging in value from 1 to 5, except for the Pain Intensity item which has eleven response options ranging in value from 0 to 10. A raw score is created from each short form that makes up the Profile. Raw scores are calculated by summing the values of the response to each question within each domain.
Outcome measures
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=212 Participants
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
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 percent
Standard Deviation 6.28
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The PROMIS Global Health short form is a validated, 10-item instrument designed to assess multiple health domains. The questionnaire yields a total score and sub-scale scores for Global Physical and Mental Health. Each question has potential five response options ranging in value from one to five to give a total score ranging from 10 to 50. All questions must be answered to arrive at a total score as one or more missing responses will render scores unusable. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better global health.
Outcome measures
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=426 Participants
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
Physical Health
|
6.22 percent
Standard Deviation 7.25
|
|
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
Mental Health
|
4.42 percent
Standard Deviation 8.19
|
Adverse Events
Dorsal Root Ganglion (DRG) Stimulation
Serious adverse events
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=426 participants at risk
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.23%
1/426 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Community Acquired Pneumonia
|
0.23%
1/426 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.23%
1/426 • 12 months
|
|
Psychiatric disorders
Altered Mental Status
|
0.23%
1/426 • 12 months
|
|
Surgical and medical procedures
Ankle Surgery
|
0.23%
1/426 • 12 months
|
|
General disorders
Bone Fracture
|
0.23%
1/426 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Tumor
|
0.23%
1/426 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Diagnosis
|
0.23%
1/426 • 12 months
|
|
Vascular disorders
Cerebrovascular Accident
|
0.23%
1/426 • 12 months
|
|
General disorders
Chest Pain
|
0.23%
1/426 • 12 months
|
|
Cardiac disorders
Congestive Heart Failure
|
0.23%
1/426 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Covid Associated Pneumonia
|
0.23%
1/426 • 12 months
|
|
Gastrointestinal disorders
Crohns Disease Flare Up
|
0.23%
1/426 • 12 months
|
|
General disorders
Death
|
0.70%
3/426 • 12 months
|
|
General disorders
Dizziness and Chest Pain
|
0.23%
1/426 • 12 months
|
|
General disorders
Embolism
|
0.47%
2/426 • 12 months
|
|
General disorders
Epistaxis
|
0.23%
1/426 • 12 months
|
|
General disorders
Escalating Pain
|
0.23%
1/426 • 12 months
|
|
General disorders
Fall
|
0.23%
1/426 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal or Genitourinary Compromise
|
0.47%
2/426 • 12 months
|
|
Infections and infestations
Infection
|
0.23%
1/426 • 12 months
|
|
Infections and infestations
Infection in Foot
|
0.23%
1/426 • 12 months
|
|
Infections and infestations
Knee Infection
|
0.23%
1/426 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.23%
1/426 • 12 months
|
|
General disorders
Numbness
|
0.23%
1/426 • 12 months
|
|
General disorders
Patient Had Sub-Acute CVA 7 Days After Trial
|
0.23%
1/426 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
5/426 • 12 months
|
|
General disorders
Right Ankle Fracture
|
0.23%
1/426 • 12 months
|
|
Infections and infestations
Sepsis
|
0.23%
1/426 • 12 months
|
|
Cardiac disorders
St Elevation Myocardial Infarction
|
0.23%
1/426 • 12 months
|
|
General disorders
Toe Amputation
|
0.23%
1/426 • 12 months
|
|
General disorders
Unrelated Trauma
|
0.23%
1/426 • 12 months
|
|
General disorders
Vertebral Compression Fracture
|
0.23%
1/426 • 12 months
|
Other adverse events
| Measure |
Dorsal Root Ganglion (DRG) Stimulation
n=426 participants at risk
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System): Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System): Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
|
|---|---|
|
General disorders
Clumsiness
|
0.47%
2/426 • 12 months
|
|
General disorders
Dizziness
|
0.23%
1/426 • 12 months
|
|
Injury, poisoning and procedural complications
Pain at the Implant Site
|
0.23%
1/426 • 12 months
|
|
Nervous system disorders
Tibial Nerve Surgery
|
0.23%
1/426 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor Review. Principal investigator and Institution shall provide a copy of any abstract, presentation, journal, manuscript (written by Principal Investigator or Study Staff) and all related materials relating to the Study to Sponsor at least sixty (60) days prior to the proposed submission date.
- Publication restrictions are in place
Restriction type: OTHER