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Completed

NCT Number: NCT03277378

Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial

Prospective, multi-center, randomized, single blind study

Completed

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Key information

Conditions

Chronic, Intractable Pain of the Trunk and/or Lower Limbs Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frankston Pain Management, Frankston, Australia

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About this study

This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:

Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
  • Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
  • 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.
  • 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.
  • Patient is >18 years of age at the time of enrollment.
  • Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
  • Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.

Exclusion criteria

  • Patient currently has a spinal cord stimulation system implanted.
  • Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
  • Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
  • Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
  • Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

Treatment and study plan

lead placement followed by BurstDR stimulation

Device

lead placement followed by BurstDR stimulation

Other names: Spinal Cord Stimulation non-surgical Leads, Spinal Cord Stimulation Clinician Programmer, Spinal Cord Stimulation Patient Controller

Primary outcomes

  1. Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    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

Secondary outcomes

  1. Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    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.

Other outcomes

  1. Procedural Characteristics of Subjects With One Trial Lead Implanted (US)

    Time frame: Trial system implant

    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.

  2. Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)

    Time frame: Trial system implant

    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.

  3. Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)

    Time frame: Trial system implant

    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.

  4. Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)

    Time frame: Trial system implant

    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.

  5. Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)

    Time frame: Trial system implant

    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.

  6. Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)

    Time frame: Trial system implant

    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.

  7. Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)

    Time frame: Trial system implant

    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.

  8. Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)

    Time frame: Trial system implant

    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.

  9. Programming Time Needed for Each Randomized Group

    Time frame: Trial system implant

    The programming time observed for both randomized groups

  10. Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    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.

  11. Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period

    Time frame: 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

    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.

  12. Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant

  13. Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.

  14. Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")

  15. Rate of Serious Adverse Device Effects (SADE) Based on Randomization

    Time frame: From pre-implant to exit of the study, approximately 3 to 14 days

    Rate of serious adverse device effects based on each randomized group.

  16. Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response

  17. Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type

    Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

    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

  18. Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty

    Time frame: Trial system implant

    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.

  19. Clinician Affinity for Lead Placement Technique at the End of Trial Procedure

    Time frame: Trial system implant

    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'.

  20. Permanent System Qualification Rate at the End of Extended Trial Period

    Time frame: 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

    The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)

Acronym: DELIVERY

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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