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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.
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 Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsal Root Ganglion (DRG) Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) | Device | Electrical stimulation of the DRG using the Axium™ Neurostimulator System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Serious Adverse Events (SAEs) | 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. | throughout 12 month study |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects aged 22 to 75 with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II with a baseline VAS score of 6 or greater.
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| Name | Affiliation | Role |
|---|---|---|
| Ann Jannu, PhD, CCRP | Abbott Neuromodulation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pain Specialists | Scottsdale | Arizona | 85258 | United States | ||
| Spanish Hills Interventional Pain Specialists |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2022 | Oct 16, 2022 |
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| Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) | Device | Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System. |
|
| 12 months |
| 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 | 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. | 12 months |
| Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale | 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. | 12 months |
| Camarillo |
| California |
| 93010 |
| United States |
| California Orthopedics & Spine | Larkspur | California | 94939 | United States |
| Loma Linda University Hospital | Loma Linda | California | 92354 | United States |
| VA Loma Linda Healthcare System | Loma Linda | California | 92357 | United States |
| University of California - San Francisco | San Francisco | California | 94143 | United States |
| Orthopedic Pain Specialists | Santa Monica | California | 90403 | United States |
| Summit Pain Alliance Inc. | Santa Rosa | California | 95401 | United States |
| Pacific Research Institute | Santa Rosa | California | 95403 | United States |
| Front Range Pain Medicine | Fort Collins | Colorado | 80525 | United States |
| Coastal Orthopedics & Sports Medicine Southwest FL | Bradenton | Florida | 34209 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida - Department of Anesthesia | Gainesville | Florida | 32610 | United States |
| Florida Pain Institute | Merritt Island | Florida | 32953 | United States |
| Better Health Clinical Research | Newnan | Georgia | 30265 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Goodman Campbell Brain & Spine | Indianapolis | Indiana | 46260 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Nura | Edina | Minnesota | 55435 | United States |
| Twin Cities Pain Clinic | Edina | Minnesota | 55439 | United States |
| Advanced Pain Care | Henderson | Nevada | 89052 | United States |
| Nevada Advanced Pain Specialists | Reno | Nevada | 89511 | United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| The Spine & Pain Institute of New York | Staten Island | New York | 10305 | United States |
| Premier Pain Solutions | Asheville | North Carolina | 28803 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Adena Bone and Joint Center | Chillicothe | Ohio | 45601 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Pacific Sports and Spine | Eugene | Oregon | 97404 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Spinal Diagnostics | Tualatin | Oregon | 97062 | United States |
| Center for Intervetional Pain and Spine | Exton | Pennsylvania | 19341 | United States |
| Main Line Spine | King of Prussia | Pennsylvania | 19406 | United States |
| Thomas Jefferson Department of Neurosurgery | Philadelphia | Pennsylvania | 19107 | United States |
| Pain Diagnostics and Interventional Care | Sewickley | Pennsylvania | 15143 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Carolinas Center for Advanced Management of Pain | Greenville | South Carolina | 29615 | United States |
| Vertex Spine and Pain | Franklin | Tennessee | 37067 | United States |
| Central Texas Pain Institute | Killeen | Texas | 76542 | United States |
| Advanced Pain Solutions | Mesquite | Texas | 75150 | United States |
| Shannon Clinic | San Angelo | Texas | 76903 | United States |
| The Spine and Nerve Center of St. Francis | Charleston | West Virginia | 25301 | United States |
| Advanced Pain Management | Greenfield | Wisconsin | 53221 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Complex Regional Pain Syndrome (CRPS) | Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II. Type I occurs when there is no confirmed nerve injury. Type II is when there is known associated nerve injury. The enrolling physicians diagnosed the CRPS type. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Serious Adverse Events (SAEs) | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Error | percentage of events | throughout 12 month study |
|
|
| |||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS) | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percent | 12 months |
|
| ||||||||||||||||||||||||||
| 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 | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percent | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percent | 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 426 | 26 | 426 | 5 | 426 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Standard Terminology | Systematic Assessment |
| |
| Acute Community Acquired Pneumonia | Respiratory, thoracic and mediastinal disorders | Standard Terminology | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Standard Terminology | Systematic Assessment |
| |
| Altered Mental Status | Psychiatric disorders | Standard Terminology | Systematic Assessment |
| |
| Ankle Surgery | Surgical and medical procedures | Standard Terminology | Systematic Assessment |
| |
| Bone Fracture | General disorders | Standard Terminology | Systematic Assessment |
| |
| Brain Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Standard Terminology | Systematic Assessment |
| |
| Breast Cancer Diagnosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Standard Terminology | Systematic Assessment |
| |
| Cerebrovascular Accident | Vascular disorders | Standard Terminology | Systematic Assessment |
| |
| Chest Pain | General disorders | Standard Terminology | Systematic Assessment |
| |
| Congestive Heart Failure | Cardiac disorders | Standard Terminology | Systematic Assessment |
| |
| Covid Associated Pneumonia | Respiratory, thoracic and mediastinal disorders | Standard Terminology | Systematic Assessment |
| |
| Crohns Disease Flare Up | Gastrointestinal disorders | Standard Terminology | Systematic Assessment |
| |
| Death | General disorders | Standard Terminology | Systematic Assessment |
| |
| Dizziness and Chest Pain | General disorders | Standard Terminology | Systematic Assessment |
| |
| Embolism | General disorders | Standard Terminology | Systematic Assessment |
| |
| Epistaxis | General disorders | Standard Terminology | Systematic Assessment |
| |
| Escalating Pain | General disorders | Standard Terminology | Systematic Assessment |
| |
| Fall | General disorders | Standard Terminology | Systematic Assessment |
| |
| Gastrointestinal or Genitourinary Compromise | Gastrointestinal disorders | Standard Terminology | Systematic Assessment |
| |
| Infection | Infections and infestations | Standard Terminology | Systematic Assessment |
| |
| Infection in Foot | Infections and infestations | Standard Terminology | Systematic Assessment |
| |
| Knee Infection | Infections and infestations | Standard Terminology | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | Standard Terminology | Systematic Assessment |
| |
| Numbness | General disorders | Standard Terminology | Systematic Assessment |
| |
| Patient Had Sub-Acute CVA 7 Days After Trial | General disorders | Standard Terminology | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Standard Terminology | Systematic Assessment |
| |
| Right Ankle Fracture | General disorders | Standard Terminology | Systematic Assessment |
| |
| Sepsis | Infections and infestations | Standard Terminology | Systematic Assessment |
| |
| St Elevation Myocardial Infarction | Cardiac disorders | Standard Terminology | Systematic Assessment |
| |
| Toe Amputation | General disorders | Standard Terminology | Systematic Assessment |
| |
| Unrelated Trauma | General disorders | Standard Terminology | Systematic Assessment |
| |
| Vertebral Compression Fracture | General disorders | Standard Terminology | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clumsiness | General disorders | Standard Terminology | Systematic Assessment |
| |
| Dizziness | General disorders | Standard Terminology | Systematic Assessment |
| |
| Pain at the Implant Site | Injury, poisoning and procedural complications | Standard Terminology | Systematic Assessment |
| |
| Tibial Nerve Surgery | Nervous system disorders | Standard Terminology | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Harbert | Abbott Vascular | (972) 526-4841 | Nicole.harbert@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2021 | Oct 16, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
|