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This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMedâ„¢ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.
Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Therapy | Other | Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMedâ„¢ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic SynchroMedâ„¢ II infusion system | Device | Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTMâ„¢). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success at the 6-Month Visit | To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented. | Baseline to 6-Month Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit | To demonstrate pain intensity scores (Visual Analog Scale, VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, with a non-inferiority margin of 10mm. Pain was assessed using a Visual Analog Scale, ranging from 0-100, where 0 is no pain and 100 is the worst pain. The VAS is a 100mm line, with "No pain" on the left side of the line and "Worst pain imaginable" on the right side of the line. Subjects made a perpendicular mark on the VAS line that best describes their average pain in the last 24 hours. Change in VAS is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroversion | Anchorage | Alaska | 99508 | United States | ||
| Coastal Pain and Spinal Diagnostics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12351602 | Background | Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE; Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002 Oct 1;20(19):4040-9. doi: 10.1200/JCO.2002.02.118. | |
| 22845187 |
| Label | URL |
|---|---|
| Applicable Product Manual(s) for the SynchroMed II infusion system | View source |
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Subjects are considered enrolled at the time the informed consent form is signed. At the Baseline Visit, consented subjects are assessed for eligibility to the study-specific inclusion and exclusion criteria. Subjects who meet all eligibility criteria begin the systemic opioid weaning process prior to initiating the intrathecal drug trial. Subjects with a successful intrathecal trial are eligible for an Intrathecal Drug Delivery System Implant. Non-implanted subjects are exited from the study.
Subjects were enrolled from 2019 through 2021 at 16 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Subjects | All consented subjects are considered enrolled in the study. Enrolled subjects do not receive a treatment intervention before Intrathecal Trial. Subjects who met eligibility criteria proceeded to the Intrathecal Trial procedure. The intrathecal drug trial was conducted according to the investigator's standard of care procedures. A successful intrathecal trial was determined by the investigator. Subjects with a successful intrathecal trial were eligible for implant of the Intrathecal Drug Delivery System (IDDS). Subjects who were implanted with the IDDS were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with utilization of the lowest reasonable daily dose of IT PFMS. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment to Implant |
|
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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 | Apr 26, 2021 | Sep 7, 2022 |
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| Preservative-free morphine sulfate (PFMS) | Drug | The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS). |
|
| Baseline to 6-Month Visit |
| Numerical Opioid Side Effect (NOSE) Assessment Tool | To characterize the change in opioid-related side effects scores (NOSE) from Baseline to the 6-Month Visit. The Numerical Opioid Side Effect (NOSE) Assessment Tool is a tool to evaluate 10 opioid-related side effects using a 11-point numerical scale. Subjects are asked to evaluate each of the 10 opioid-related side effects on a scale of 0 - 10 with 0 being "not present" and 10 being "as bad as you can imagine". A total sum score can range from 0 - 100, where 0 is no opioid-related side effects and 100 is the worst opioid-related side effects. Change in NOSE is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in opioid-related side effects. | Baseline to 6-Month Visit |
| Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit | To characterize the number of subjects who eliminate systemic opioids through the 6-Month Visit. Four drug tests for systemic opioid use are administered from intrathecal therapy initiation through the 6-Month Visit. If all of the available drug tests are negative for systemic opioid use, the subject is counted as eliminating systemic opioids through the 6-Month Visit. The number of subjects who eliminated systemic opioids through the 6-Month Visit is presented. | Baseline to 6-Month Visit |
| Carlsbad |
| California |
| 92009 |
| United States |
| Napa Valley Orthopaedic Medical Group | Napa | California | 94558 | United States |
| Florida Pain Institute | Merritt Island | Florida | 32935 | United States |
| Regional Brain & Spine, LLC | Cape Girardeau | Missouri | 63701 | United States |
| Christian Hospital Pain Management | St Louis | Missouri | 63136 | United States |
| Comprehensive and Interventional Pain Management | Henderson | Nevada | 89052 | United States |
| The Pain Management Center | Voorhees Township | New Jersey | 08043 | United States |
| Premier Pain Treatment Institute | Mount Orab | Ohio | 45154 | United States |
| Clinical Investigations, LLC | Edmond | Oklahoma | 73013 | United States |
| Moss Rehabilitation-Einstein Healthcare Network | Elkins Park | Pennsylvania | 19027 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| University of Virginia Pain Management Center | Charlottesville | Virginia | 22908 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Northwest Pain Care, Inc. | Spokane | Washington | 99201 | United States |
| Background |
| Hamza M, Doleys D, Wells M, Weisbein J, Hoff J, Martin M, Soteropoulos C, Barreto J, Deschner S, Ketchum J. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30. |
| 26477685 | Background | Grider JS, Etscheidt MA, Harned ME, Lee J, Smith B, Lamar C, Bux A. Trialing and Maintenance Dosing Using a Low-Dose Intrathecal Opioid Method for Chronic Nonmalignant Pain: A Prospective 36-Month Study. Neuromodulation. 2016 Feb;19(2):206-19. doi: 10.1111/ner.12352. Epub 2015 Oct 19. |
| 26307558 | Background | Hamza M, Doleys DM, Saleh IA, Medvedovsky A, Verdolin MH, Hamza M. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain. Neuromodulation. 2015 Oct;18(7):636-48; discussion 649. doi: 10.1111/ner.12342. Epub 2015 Aug 26. |
| 29016893 | Background | Wilkes DM, Orillosa SJ, Hustak EC, Williams CG, Doulatram GR, Solanki DR, Garcia EA, Huang LM. Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics. Pain Med. 2018 Sep 1;19(9):1782-1789. doi: 10.1093/pm/pnx132. |
| 21785477 | Background | Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug;14(4):343-51. |
| Intrathecal Trial |
|
| COMPLETED |
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| NOT COMPLETED |
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| Post-Implant to 6 Months |
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| 6 Months to 12 Months |
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The Baseline Analysis Population (n=52) is the subset of enrolled subjects who completed the intrathecal trial and were implanted with an Implantable Drug Delivery System (IDDS). Within the 93 enrolled subjects, 21 exited prior to the intrathecal trial, 20 exited after intrathecal trial and before IDDS implant, and 52 received an IDDS implant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted Drug Delivery Subjects | All subjects implanted with the Intrathecal Drug Delivery System (IDDS). Subjects were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS. The following IT PFMS dose initiation parameters were recommended: (1) A starting PFMS dose of 0.1 to 0.5 mg/day, or half the effective trial dose, with lower initial PFMS doses considered, and (2) a starting concentration to achieve an estimated pump refill interval of 120 days, but not to exceed 180 days. IT PFMS dose increases or decreases could be made any time throughout the duration of study. |
| 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 |
| ||||||||||||||||||
| Pain (Visual Analog Scale, VAS, 0-100) | Pain was assessed with the Visual Analog Scale, ranging from 0-100, where 0 is no pain and 100 is the worst pain. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Numerical Opioid Side Effect Assessment (NOSE, 0-100) | Opioid-related side effects were assessed using the Numerical Opioid Side Effect Assessment, ranging from 0-100, where 0 is no opioid-related side effects and 100 is the worst opioid-related side effects. | Mean | Standard Deviation | units on a scale |
|
| 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 | Number of Participants With Clinical Success at the 6-Month Visit | To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented. | A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant. | Posted | Count of Participants | Participants | Baseline to 6-Month Visit |
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| Secondary | Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit | To demonstrate pain intensity scores (Visual Analog Scale, VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, with a non-inferiority margin of 10mm. Pain was assessed using a Visual Analog Scale, ranging from 0-100, where 0 is no pain and 100 is the worst pain. The VAS is a 100mm line, with "No pain" on the left side of the line and "Worst pain imaginable" on the right side of the line. Subjects made a perpendicular mark on the VAS line that best describes their average pain in the last 24 hours. Change in VAS is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in pain intensity. | A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 6-Month Visit |
| |||||||||||||||||||||||||||
| Secondary | Numerical Opioid Side Effect (NOSE) Assessment Tool | To characterize the change in opioid-related side effects scores (NOSE) from Baseline to the 6-Month Visit. The Numerical Opioid Side Effect (NOSE) Assessment Tool is a tool to evaluate 10 opioid-related side effects using a 11-point numerical scale. Subjects are asked to evaluate each of the 10 opioid-related side effects on a scale of 0 - 10 with 0 being "not present" and 10 being "as bad as you can imagine". A total sum score can range from 0 - 100, where 0 is no opioid-related side effects and 100 is the worst opioid-related side effects. Change in NOSE is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in opioid-related side effects. | A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6-Month Visit |
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| Secondary | Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit | To characterize the number of subjects who eliminate systemic opioids through the 6-Month Visit. Four drug tests for systemic opioid use are administered from intrathecal therapy initiation through the 6-Month Visit. If all of the available drug tests are negative for systemic opioid use, the subject is counted as eliminating systemic opioids through the 6-Month Visit. The number of subjects who eliminated systemic opioids through the 6-Month Visit is presented. | The subset of Targeted Drug Delivery Subjects who have a drug test at the 6-Month Visit and no more than 1 missing drug test through the 6-Month Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, 42 maintained ITMM through the 6M Visit, and 41 completed a drug test at the 6-Month and had no more than 1 missing drug test through the 6-Month Visit. | Posted | Count of Participants | Participants | Baseline to 6-Month Visit |
|
Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
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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 | Enrolled Subjects | All consented subjects are considered enrolled in the study. Enrolled subjects do not receive a treatment intervention before Intrathecal Trial. Subjects who met eligibility criteria proceeded to the Intrathecal Trial procedure. The intrathecal drug trial was conducted according to the investigator's standard of care procedures. A successful intrathecal trial was determined by the investigator. Subjects with a successful intrathecal trial were eligible for implant of the Intrathecal Drug Delivery System (IDDS). Subjects who were implanted with the IDDS were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS. | 1 | 93 | 20 | 93 | 18 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Implant site infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Wound infection pseudomonas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary retention | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA (24.0) | Systematic Assessment |
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Protocol V3.0 revised the last study visit from the 12-Month Visit to the 6-Month Visit at a point in the study where some subjects, but not all, had already progressed beyond the 6-Month Visit. Thus, subjects consented under Protocol V3.0 may complete the study without completing the 12-Month Visit. This protocol revision did not impact the Primary and Secondary endpoints, which are evaluated at 6 months.
No manuscripts, abstracts, or case reports that jeopardize the primary publication will be submitted prior to the submission of the primary publication. It is required that all publications undergo review at Medtronic for confidential information and technical accuracy prior to publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pain Therapies Clinical Research Director | Medtronic Neuromodulation Clinical Research | 763-514-4000 | rs.embracetdd@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2021 | Sep 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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