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

CompletedNot applicableNCT03277378
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Prospective, multi-center, randomized, single blind study

Study details

Official title
Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
Conditions
  • Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Interventions
  • Device: lead placement followed by BurstDR stimulation
Sponsor
Abbott Medical Devices
Start date
2017-09-22
Primary completion
2018-08-23
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Australia, Austria, Germany, Italy, Netherlands, Sweden, United States
Total sites listed
25

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03277378