Clinical trials: Dorsal Root Ganglion
Chronic Lower Limb Pain
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral…
- Trial name
- ACCURATE (NCT01923285)
- Testing
- AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
- Where
- 22 sites in United States
- Volunteers
- 152 people
- Sponsor
- Abbott Medical Devices
Failed Back Surgery Syndrome
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)
18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back…
- Trial name
- SYMPATHY (NCT02335216)
- Testing
- Implantation with the commercially available Axium neurostimulator
- Where
- Netherlands
- Volunteers
- 22 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.
- Trial name
- CHARACTER SCS (NCT02250469)
- Testing
- Treatment with the Axium SCS system, Treatment with the Medtronic SCS System
- Where
- Netherlands
- Volunteers
- 5 people
- Sponsor
- Abbott Medical Devices
Spinal; Nerve Root, Pain, Pelvic Pain
Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.
- Conditions
- Spinal; Nerve Root, Pain, Pelvic Pain, Regional Pain Syndrome, Chronic Pain Syndrome
- Trial name
- ACTIVE (NCT03417973)
- Testing
- dorsal root ganglion neuromodulation
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- KM Clinical Research Group
Post Surgical Groin Pain
Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain
25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain.
- Trial name
- GASPA (NCT02337699)
- Testing
- Implantation with the commercially available Axium neurostimulator, QST Testing
- Where
- Netherlands
- Volunteers
- 1 people
- Sponsor
- Abbott Medical Devices
Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days.
- Trial name
- NCT03285113
- Testing
- GiMer Medical MN 1000 External Stimulator
- Where
- Taiwan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- GiMer Medical
Chronic Pain
Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments.
- Trial name
- NCT02587637
- Testing
- Dorsal root ganglion (DRG) stimulation
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Chronic Post Surgical Pain
A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain
20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical pain
- Trial name
- NCT02335229
- Testing
- Axium DRG Neurostimulator
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Post Surgical Groin Pain
a BavaRiAn eValuatiOn of Dorsal Root Ganglion (DRG) Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin
15-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical groin pain
- Trial name
- BRAVO (NCT02346656)
- Testing
- Implantation with the commercially available Axium neurostimulator
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Abbott Medical Devices
Complex Regional Pain Syndrome (CRPS)
TARGET Post-Approval Study
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation.
- Trial name
- TARGET PAS (NCT02800863)
- Testing
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Where
- 44 sites in United States
- Volunteers
- 426 people
- Sponsor
- Abbott Medical Devices
Post Herpetic Neuralgia, Pain
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy…
- Conditions
- Post Herpetic Neuralgia, Pain, Osteoarthritis, Neuropathic Pain
- Trial name
- NCT06218784
- Testing
- iN1011-N17 HCl Suspension (Part 1), iN1011-N17 HCl Capsule (Part 1), iN1011-N17 HCl Capsule (Part 2)
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- iN Therapeutics Co., Ltd.
Pain, Chronic, Pain, Radiating
Change in Pain and Quality of Life Following SCS for Chronic Pain
Study Title Subject-reported treatment efficacy and procedure satisfaction (steps) study.BURST study- a prospective observational clinical study examining the changes in quality of life and pain following spinal cord stimulation…
- Conditions
- Pain, Chronic, Pain, Radiating, Pain, Back, Pain Syndrome
- Trial name
- BURST (NCT03421951)
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- KM Clinical Research Group
Chronic Pain
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's…
- Trial name
- REALITY (NCT03876054)
- Testing
- Spinal cord stimulation (SCS), Dorsal root ganglion stimulation (DRG)
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 2,000 people
- Sponsor
- Abbott Medical Devices