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Clinical Trials – Medical Devices

Medical device clinical trials are important for the development of new medical technologies and improvement of existing technologies. Our involvement with a number of local and international device companies means that patients have access to potential new treatment options and potentially better outcomes, particularly in the field of chronic pain.

Read our medical devices blog for more information about this type of therapy.

A list of medical device trials that have been conducted at Genesis Research Services appears below.

A Prospective, Open-Label, Multi-Center Trial to Evaluate the Safety and Effectiveness of Ultra Low Frequency Spinal Cord Stimulation in Patients With Chronic Low Back Pain.
  • Year: 2023
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera™ SCS System With HomeStream™ Remote Management.
  • Year: 2022
  • Type: Device
  • Phase: First-in-Human
  • Indication: Back and/or Leg Pain
Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop SCS System (ClosedLoop SCS study).
  • Year: 2022
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain, Neck / Upper Limb Pain
Freshwater: A prospective, multicentre, single-arm feasibility study examining novel treatment delivery of the Evoke Spinal Cord Stimulator (SCS) System to treat patients with chronic pain of the trunk and/or limbs.
  • Year: 2021
  • Type: Device
  • Phase: Post-Market
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain, Neck / Upper Limb Pain
Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic Neuropathy.
  • Year: 2021
  • Type: Device
  • Phase: Pre-Market
  • Indication: Painful Diabetic Neuropathy
A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF-2).
  • Year: 2019
  • Type: Device
  • Phase: Post-Market
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain, Neck / Upper Limb Pain
A Randomized, Controlled, Multi-Center, Non-inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with / without Leg Pain.
  • Year: 2020
  • Type: Device
  • Phase: Pre-Market
  • Indication: Back and/or Leg Pain
A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the Treatment of Chronic Pain.
  • Year: 2012
  • Type: Device
  • Phase: N/A
  • Indication: Chronic Trunk and/or Limb Pain
Precision High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain.
  • Year: 2012
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain
Partnership for Advancement in Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry.
  • Year: 2012
  • Type: Device
  • Phase: Post-Market
  • Indication: Chronic Trunk and/or Limb Pain
SCS Heart Study- Spinal Cord Stimulation for heart Failure as a Restorative Treatment.
  • Year: 2013
  • Type: Device
  • Phase: First-in-Human
  • Indication: Other
SubQStim: Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS).
  • Year: 2013
  • Type: Device
  • Phase: IV
  • Indication: Back and/or Leg Pain
OPTIONS Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs.
  • Year: 2013
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain
An investigation into the therapeutic effect of electrical impulses with short pulse (SP) width on pain relief and quality of the spinal cord stimulation (SCS) in patients with intractable back and / or leg pain.
  • Year: 2013
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain
A Multicenter Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients.
  • Year: 2013
  • Type: Device
  • Phase: Post-Market
  • Indication: CRPS
BURST Pre-Market Clinical Study.
  • Year: 2014
  • Type: Device
  • Phase: Pre-Market
  • Indication: Back and/or Leg Pain
A feasibility study evaluating the Saluda SCS system incorporating feedback control using Evoked Compound Action Potentials (ECAP) to aid in the accurate positioning of Spinal Cord Stimulation (SCS) leads.
  • Year: 2014
  • Type: Device
  • Phase: Pre-Market
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain
A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF).
  • Year: 2014
  • Type: Device
  • Phase: Post-Market
  • Indication: Chronic Trunk and/or Limb Pain
Investigation of the ReActiv8® Implantable Stimulation System for Chronic Low Back Pain (ReActiv8-A).
  • Year: 2014
  • Type: Device
  • Phase: Pre-Market
  • Indication: Back and/or Leg Pain
Multi-Centre, Prospective Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pain.
  • Year: 2016
  • Type: Device
  • Phase: Pre-Market
  • Indication: Neck / Upper Limb Pain
Avalon: A study to evaluate the safety and performance of a new Spinal Cord Stimulation System using automatic control to treat patients with chronic pain.
  • Year: 2016
  • Type: Device
  • Phase: Pre-Market
  • Indication: Back and/or Leg Pain, Chronic Trunk and/or Limb Pain, Neck / Upper Limb Pain
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B).
  • Year: 2017
  • Type: Device
  • Phase: Pre-Market
  • Indication: Back and/or Leg Pain
A Prospective, Single-Blinded, Dose-Response Study of SCS Therapy using Subthreshold Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain.
  • Year: 2018
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain
A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord Stimulation.
  • Year: 2019
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain
A Data Acquisition Study for the Tournicare Blood Pressure Monitor
  • Year: 2019
  • Type: Device
  • Phase: Pre-Market
  • Indication: Healthy
Buffered GEnipin Microinvasive Device for Treatment of Low Back Pain from Degenerative Disc Disease – CE Marking Safety and Efficacy Study (GEM-SE).
  • Year: 2019
  • Type: Device
  • Phase: II
  • Indication: Back and/or Leg Pain
A Multi-Center, Prospective Clinical Trial of Spinal Cord Stimulation with Varying Parameters for the Treatment of Chronic Back and/or Leg Pain.
  • Year: 2019
  • Type: Device
  • Phase: N/A
  • Indication: Back and/or Leg Pain
Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of Low Frequency Spinal Cord Stimulator in Subjects with Low Back and/or Leg Pain.
  • Year: 2019
  • Type: Device
  • Phase: First-in-Human
  • Indication: Back and/or Leg Pain