Chronic, Intractable Pain of the Trunk and/or Lower Limbs Clinical Trial
— DELIVERYOfficial title:
Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
| Verified date | December 2020 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prospective, multi-center, randomized, single blind study
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | October 12, 2018 |
| Est. primary completion date | August 23, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling. 2. Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage. 3. Patient has a baseline score on the Numerical Rating Scale =6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation. 4. Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use. 5. Patient is >18 years of age at the time of enrollment. 6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits. 7. Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent. Exclusion Criteria: 1. Patient currently has a spinal cord stimulation system implanted. 2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant). 3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine. 4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure) 5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s). |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Frankston Pain Management | Frankston | |
| Australia | North Shore Private Hospital | Saint Leonards | |
| Austria | Hospital Elisabethinen GmbH | Graz | |
| Austria | Wilhelminenspital Wien | Vienna | |
| Germany | Sana Kliniken Duisburg Gm.bH | Duisburg | |
| Germany | Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | |
| Germany | Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie | Gera | |
| Germany | Klinikum Nürnberg Sud | Nürnberg | |
| Italy | Fondazione Salvatore Maugeri | Pavia | |
| Netherlands | Alrijne Ziekenhuis | Leiderdorp | |
| Netherlands | Stichting Rijnstate Ziekenhuis - Velp | Velp | |
| Sweden | University Hospital | Uppsala | |
| United States | Rush University | Chicago | Illinois |
| United States | Comprehensive Spine Institute | Clearwater | Florida |
| United States | St. Mary's Hospital | Huntington | West Virginia |
| United States | Kansas University Medical Center | Kansas City | Kansas |
| United States | Advanced Pain Care | Las Vegas | Nevada |
| United States | Florida Pain Institute | Merritt Island | Florida |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Nevada Advanced Pain Specialists | Reno | Nevada |
| United States | Jason Edward Pope, MD | Santa Rosa | California |
| United States | Spinal Diagnostics | Tualatin | Oregon |
| United States | Precision Spine Care | Tyler | Texas |
| United States | National Pain Institute Winter Park | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Australia, Austria, Germany, Italy, Netherlands, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured. | Trial system implant | |
| Other | Programming Time Needed for Each Randomized Group | The programming time observed for both randomized groups | Trial system implant | |
| Other | Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period | Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Other | Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period | Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. | From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation | |
| Other | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Other | Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion. | Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion. | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Other | Time From Trial System to = 50% Patient Reported Pain Relief (PRP) | Time from trial system to = 50% patient reported pain relief measured by the number of days (also known as " wash-in period") | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Other | Rate of Serious Adverse Device Effects (SADE) Based on Randomization | Rate of serious adverse device effects based on each randomized group. | From pre-implant to exit of the study, approximately 3 to 14 days | |
| Other | Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group | A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Other | Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type | The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Other | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure. | Trial system implant | |
| Other | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'. | Trial system implant | |
| Other | Permanent System Qualification Rate at the End of Extended Trial Period | The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period. | From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation | |
| Primary | Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period | The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.
Qualification for permanent system implant was defined by a composite where all the following conditions were met: = 50% patient reported pain relief (PRP) at the end of the trial evaluation Trial evaluation period lasted for a minimum of 3 days Physician recommends subject for permanent system implant Subject reports a willingness to pursue a permanent system implant Subjects did not qualify for permanent system implant if they met both of the following: < 50% PRP (patient reported pain relief) at the end of the trial evaluation Trial evaluation period lasted for a minimum of 5 days |
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | |
| Secondary | Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study | The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique. | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation |