Research

Spine - Lumbar

3Spine BalanceBack TLIF Study: A research study of lumbar spine degeneration that is being treated surgically with a transforaminal lumbar interbody fusion (TLIF) procedure. 3Spine, the study sponsor, is conducting a research study to collect safety and efficacy information on subjects who undergo this procedure. More information is available at: https://www.clinicaltrials.gov/ct2/results?cond=&term=TLIF+3Spine&cntry=&state=&city=&dist=

Stryker Adherus Study: A study to test an investigational device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures compared to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures. More information is available at: https://www.clinicaltrials.gov/ct2/show/NCT04498026?term=adherus+dural&draw=2&rank=2

 
TOPS IDE Artificial Facet: The study is designed to assess the ability of the TOPS System to relieve the pain and restore normal function caused by certain spinal conditions. The purpose of the study is to compare the results of spinal surgery using the TOPS System to the results of spinal fusion surgery. Currently, fusion surgery is a standard treatment for people with these symptoms. The spinal column is made up of many joints which allow the body to bend, twist and move. Pain often results when there is something wrong with these joints. Fusing diseased vertebrae together stabilizes the spine. However, fusing the vertebral bones also makes them incapable of moving normally. A spinal implant such as the TOPS System is intended as an alternative to fusion surgery because it is designed to relieve pain while still allowing movement of the joints between the vertebrae.

SPINE - cervical

Spine Art Baguera One Level: The purpose of this research study is to evaluate the safety and effectiveness of the BAGUERA®C Cervical Disc Prosthesis for treating patients with neck and/or arm pain and nerve or spinal cord irritation. More information is available at: https://www.clinicaltrials.gov/ct2/results?cond=&term=spineart+baguera+one&cntry=&state=&city=&dist=

Spine Art Baguera Two Level: The purpose of this research study is to evaluate the safety and effectiveness of the BAGUERA®C Cervical Disc Prosthesis for treating patients with neck and/or arm pain and nerve or spinal cord irritation at two levels. More information is available at: https://www.clinicaltrials.gov/ct2/results?cond=&term=spineart+baguera+two&cntry=&state=&city=&dist=

Other Studies

Medtronic EMBOLISE: Embolization of the Middle Meningeal Artery for subjects who have symptomatic subacute or chronic subdural hematoma. The Onyx™ LES is approved by the U.S. Food and Drug Administration (FDA) for use in patients who have brain malformations. For this study, the Onyx™ LES will be used in patients who have symptomatic subacute or chronic SDH. The FDA has not approved Onyx™ LES for use in patients who have symptomatic subacute or chronic SDH for embolization of the MMA and the device will therefore be considered investigational for this study. More information is available at: https://www.clinicaltrials.gov/ct2/results?cond=&term=Onyx+LES+for+MMA&cntry=&state=&city=&dist=

ReSet RA: For patients with active, moderate or severe rheumatoid arthritis (RA), and who are not improving or cannot tolerate certain medications for Rheumatoid Arthritis. Subjects will have a small stimulator implanted on the vegas nerve in the neck to test if the stimulation to the nerve has an effect on their RA. More information is available at: https://www.clinicaltrials.gov/ct2/show/NCT04539964?term=Reset+RA&draw=2&rank=1

Wingspan™ Stent System with Gateway PTA Balloon Catheter: (Humanitarian Use Device)- For use in treatment of lesion within the brain, caused by atherosclerosis (narrowing and hardening of the arteries) and its affect on the neurovascular arteries that are in the brain.

Boston Scientific Target NEUROFORM™ Microdelivery Stent System (Humanitarian Use Device) – for use in treatment of wide-neck, intracranial aneurysms.