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.

Partnership for Advancement in Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry.

Sponsor:
St Jude Medical
CRO:
N/A
Study ID:
C-09-01
Phase:
Observational

SCS Heart Study- Spinal Cord Stimulation for heart Failure as a Restorative Treatment.

Sponsor:
St Jude Medical
CRO:
N/A
Study ID:
CI-10-029-ID-SC
Phase:
I

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).

Sponsor:
Medtronic
CRO:
N/A
Study ID:
1.02.7007 SubQStim
Phase:
IV

OPTIONS Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs.

Sponsor:
Boston Scientific
CRO:
N/A
Study ID:
A5004 OPTIONS
Phase:
Prospective

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.

Sponsor:
Boston Scientific
CRO:
N/A
Study ID:
SPStim: Whisper2013
Phase:
Open-Label

A Multicenter Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients.

Sponsor:
Investigator-Initiated
CRO:
N/A
Study ID:
2012-03-699
Phase:
Open-Label

BURST Pre-Market Clinical Study.

Sponsor:
St Jude Medical
CRO:
N/A
Study ID:
C-13-03 BURST
Phase:
Post-Market

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.

Sponsor:
Saluda Medical
CRO:
N/A
Study ID:
SMCSh10
Phase:
Pre-Market

A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF).

Sponsor:
Boston Scientific
CRO:
N/A
Study ID:
A7007 RELIEF
Phase:
Pre-Market

Investigation of the ReActiv8® Implantable Stimulation System for Chronic Low Back Pain (ReActiv8-A).

Sponsor:
Mainstay Medical
CRO:
Five Corners
Study ID:
950057 ReActiv8-A
Phase:
Pre-Market

Multi-Centre, Prospective Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pain.

Sponsor:
Nevro
CRO:
N/A
Study ID:
CA2013 OUS ULN
Phase:
Pre-Market

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.

Sponsor:
Saluda Medical
CRO:
N/A
Study ID:
SCLSH1502
Phase:
Pre-Market

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B).

Sponsor:
Mainstay Medical
CRO:
Five Corners
Study ID:
950002
Phase:
Pre-Market

A Prospective, Single-Blinded, Dose-Response Study of SCS Therapy using Subthreshold Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain.

Sponsor:
Investigator-Initiated
CRO:
Five Corners
Study ID:
GRS2017-001
Phase:
Open-Label

A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord Stimulation.

Sponsor:
Investigator-Initiated
CRO:
Mobius Medical
Study ID:
GRS2018-006
Phase:
Open-Label

A Data Acquisition Study for the Tournicare Blood Pressure Monitor

Sponsor:
Tournicare
CRO:
Mobius Medical
Study ID:
TOU-CIP-01
Phase:
Pre-Market

Buffered GEnipin Microinvasive Device for Treatment of Low Back Pain from Degenerative Disc Disease – CE Marking Safety and Efficacy Study (GEM-SE).

Sponsor:
Intralink Spine
CRO:
Five Corners
Study ID:
ILS-CIP-002
Phase:
Phase II

A Multi-Center, Prospective Clinical Trial of Spinal Cord Stimulation with Varying Parameters for the Treatment of Chronic Back and/or Leg Pain.

Sponsor:
Nevro
CRO:
Five Corners
Study ID:
CA2019-01 OUS DENALI
Phase:
Pre-Market

Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of Low Frequency Spinal Cord Stimulator in Subjects with Low Back and/or Leg Pain.

Sponsor:
Presidio Medical
CRO:
Five Corners
Study ID:
PMH-001
Phase:
First-in-Human