Actively Recruiting
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Led by Abbott Medical Devices · Updated on 2026-01-07
2000
Participants Needed
55
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the long-term safety and effectiveness of Abbott's neurostimulation systems in people with chronic pain. This observational study includes a wide range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. The study spans 13 years, covering enrollment, data collection, and study closure, with subjects followed for five years after implantation. Participants will receive one of Abbott's market-released neurostimulation devices, either spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG). Individuals scheduled for implantation within 60 days of baseline are eligible. The study is single-arm and open-label, meaning all participants receive the device without randomization or placebo control. During the study, researchers will monitor adverse events, deaths, and device issues at multiple time points from baseline through five years post-implant. Participants will undergo regular safety assessments and provide data on device performance and related outcomes. This comprehensive follow-up will help understand the long-term effects and real-world use of these neurostimulation systems.
CONDITIONS
Brief Title
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Subject is at least 18 years old or the minimum age required by local law to consent.
- Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
- Subject has a baseline pain numeric rating scale (NRS) score of 6 or higher without stimulation.
You will not qualify if you...
- Subject is enrolled or intends to participate in a competing clinical study.
- Subject has anatomic, medical, social, or psychological conditions limiting participation or follow-up.
- Subject has or is scheduled to receive an intrathecal pump.
- Subject is part of a vulnerable population.
- Subject has an existing implanted neuromodulation device for chronic pain.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 60 days before baseline
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 days after baseline
Participants receive implantation of an Abbott neurostimulation system, either spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG).
1 implantation visit (in-person)
Duration - 5 years
Participants are monitored for device and procedure related outcomes over 5 years after implantation.
Visits at baseline, permanent implant procedure, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5 years, and 5 years
Trial Site Locations
Total: 55 locations
1
Phoenician Centers for Research & Innovation
Phoenix, Arizona, United States, 85021
Terminated
2
Pain Institute of Southern Arizona
Tucson, Arizona, United States, 85718
Terminated
3
California Orthopedics & Spine
Larkspur, California, United States, 94939
Terminated
4
Restore Orthopedics & Spine Center
Orange, California, United States, 92868
Terminated
5
Foothills Pain Management Clinic
Pomona, California, United States, 91767
Terminated
6
Pacific Research Institute
Santa Rosa, California, United States, 95403
Terminated
7
University of Florida Department of Anesthesia
Gainesville, Florida, United States, 32610
Terminated
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Active, Not Recruiting
9
University of Chicago
Chicago, Illinois, United States, 60637
Active, Not Recruiting
10
Goodman Campbell Brain and Spine
Indianapolis, Indiana, United States, 46032
Active, Not Recruiting
11
Nura
Edina, Minnesota, United States, 55435
Active, Not Recruiting
12
Twin Cities Pain Clinic
Edina, Minnesota, United States, 55439
Terminated
13
Mayo Clinic
Rochester, Minnesota, United States, 55905
Terminated
14
Saint Louis Pain Consultants
Chesterfield, Missouri, United States, 63017
Terminated
15
Advanced Pain Care
Henderson, Nevada, United States, 89052
Terminated
16
Nevada Advanced Pain Specialists
Reno, Nevada, United States, 89511
Terminated
17
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
Terminated
18
Unity Spine Center
Rochester, New York, United States, 14626
Active, Not Recruiting
19
The Spine & Pain Institute of New York
Staten Island, New York, United States, 10305
Active, Not Recruiting
20
Premier Pain Solutions
Asheville, North Carolina, United States, 28803
Terminated
21
Adena Bone and Joint Center
Chillicothe, Ohio, United States, 45601
Withdrawn
22
Premier Pain Treatment Institute
Loveland, Ohio, United States, 45140
Withdrawn
23
Pacific Sports & Spine
Eugene, Oregon, United States, 97401
Active, Not Recruiting
24
Spinal Diagnostics
Tualatin, Oregon, United States, 97062
Terminated
25
Center for Interventional Pain & Spine
Exton, Pennsylvania, United States, 19341
Active, Not Recruiting
26
Expert Pain
Houston, Texas, United States, 77079
Active, Not Recruiting
27
Central Texas Pain Institute
Killeen, Texas, United States, 76542
Terminated
28
Integrated Pain Associates
Killeen, Texas, United States, 76542
Terminated
29
Advanced Pain Care
Round Rock, Texas, United States, 78664
Terminated
30
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, United States, 25301
Active, Not Recruiting
31
Metro Pain Group
Clayton, Victoria, Australia, 3168
Terminated
32
Precision Brain, Spine & Pain Centre
Kew, Victoria, Australia, 3101
Terminated
33
AZ Nikolaas
Sint-Niklaas, Eflndrs, Belgium, 9100
Terminated
34
AZ Delta vzw
Roeselare, West Flanders, Belgium, 8800
Terminated
35
Universitäts Klinikum Tübingen
Tübingen, Bad-wur, Germany, 72076
Terminated
36
Klinikum Ingolstadt GmbH
Ingolstadt, Bavaria, Germany, 85049
Active, Not Recruiting
37
Krankenhaus Porz am Rhein
Cologne, Koln, Germany, 51149
Actively Recruiting
38
Klinikum Duisburg GmbH
Duisburg, N. RHIN, Germany, 47055
Terminated
39
Universitaetsklinikum Duesseldorf
Düsseldorf, N. RHIN, Germany, 40225
Active, Not Recruiting
40
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach, N. RHIN, Germany, 41066
Terminated
41
Kliniken der Stadt Köln-Merheim
Cologne, North Rhine-Westphalia, Germany, 51109
Terminated
42
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Terminated
43
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
Gera, Thuringia, Germany, 07548
Terminated
44
Azienda Ospedaliera Monaldi
Naples, Campani, Italy, 80131
Active, Not Recruiting
45
Fondazione Salvatore Maugeri
Pavia, Lombard, Italy, 27100
Active, Not Recruiting
46
Erasmus MC
Rotterdam, S Holln, Netherlands, 3015
Active, Not Recruiting
47
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3435 CM
Terminated
48
Hospital Universitario de Salamanca
Salamanca, Cstleon, Spain, 37007
Terminated
49
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Terminated
50
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain, 46026
Terminated
51
Hôpital du Valais
Sion, Valais, Switzerland, 1951
Active, Not Recruiting
52
Norfolk and Norwich Hospital
Norwich, England, United Kingdom, NR4 7UY
Terminated
53
The Walton Centre
Liverpool, North West England, United Kingdom, L9 7LJ
Terminated
54
Southmead Hospital
Bristol, Sowest, United Kingdom, BS10 5NB
Terminated
55
Seacroft Hospital
Leeds, Yorkshire and the Humber, United Kingdom, LS14 6UH
Terminated
Research Team
B
Bram Blomme
S
Sonar Pradhan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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