Research


Clinical Trials

Clinical trials are research studies that rely on human volunteers to answer specific medical questions related to the treatment of disease. The results of clinical trials help determine the safest and most effective medical therapies, and shape the development of the next generation of medical treatments.

UBNS actively participates in four types of clinical trials, which represent a major component of our overall research program:

Investigational Device Exemptions (IDEs)

  • Allows an experimental medical device to be used on patients in a controlled setting in order to collect data to support a Premarket Approval application to the Food and Drug Administration (FDA). An IDE may also be used to study the effectiveness and safety of new uses for legally marketed devices.

Humanitarian Device Exemptions (HDEs)

  • Is intended to provide safety data to the FDA for the approval of a Humanitarian Use Device (HUD). HUDs are devices that diagnose or treat a disorder that affects fewer than 4,000 individuals in the United States per year. An HUD/HDE designation provides incentive for the development of devices for small populations since the research and development costs to the manufacturer may otherwise outweigh the market return. To gain FDA approval the HDE study must prove that the device does not pose an unreasonable risk of illness or injury, and that the probable benefit to health outweighs any possible risks.

Post-market Approval (PMA)

  • Is a clinical trial sometimes requested by the FDA to further test the safety and benefit of a medical device after an IDE study is complete and the device has been approved. PMAs collect long-term data to study “real-world results.” In some cases, manufacturers sponsor PMAs to obtain physician input on possible device improvements.

Physician-Sponsored

  • Is retrospective in nature, and involves the review of patient charts.

Currently, UBNS is enrolling patients in a multitude of clinical trials that treat a gamut of neurological disorders, including:

Aneurysm Studies

COAST:  The primary objective of this post-marketing study is to assess the clinical and imaging outcomes in the endovascular treatment of small (≤ 4.9 mm) intracranial aneurysms utilizing the HyperSoft® 3D (or HydroFrame®/HydroSoft® 3D in Phase II) and HyperSoft® helical coils

FEAT:  To compare angiographic outcomes in patients receiving 0.014-0.0155” platinum framing and filling coils followed by further aneurysm filling and finishing with less than 0.014” bare platinum coils (as deemed appropriate by the treating physician), versus those treated solely with coils less than 0.014”

ENTERPRISE:   A prospective, multi-center, single arm study to evaluate the safety and effectiveness of the Codman Enterprise® Vascular Reconstruction Device and Delivery System when used in conjunction with endovascular coil embolization in the treatment of wide-necked saccular intracranial aneurysms

SMART: A prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL® System

STERLING:  A prospective, multi-center, single arm study to obtain “real world” clinical data and characterize the acute and long-term performance of the MicrusFrame® and Galaxy® coils for the endovascular treatment of intracranial aneurysms

NAPA:  A prospective, multi-center, single arm study to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device used in Conjunction with Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysms

Carotid Studies

CONFIDENCE: A prospective, multicenter, single‐arm, open label clinical study to evaluate the safety and efficacy of Roadsaver™ carotid stent device used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy

CREST-2:  A two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to CEA plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to CAS plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors

CREST REGISTRY: The CREST-2 Registry (C2R) was designed to be a companion to accompany the CREST-2 trial.  Expansion of Medicare coverage for CAS to include procedures performed as part of C2R on symptomatic and asymptomatic patients beyond those categories covered under the 2005 CMS decision with the goal of improving clinical outcomes by ensuring that patients undergoing CAS were carefully selected and treated by highly proficient providers.

STANCE:  (NIH) Statin Neuroprotection and Carotid Endarterectomy: Safety, feasibility and outcomes

Stroke Studies

VITAL/VIGOR: Volumetric Integral Phase-shift Spectroscopy (VIPS) for the noninvasive detection of acute brain pathology

TIGER: Treatment with Intent to Generate Endovascular Reperfusion (TIGER)

EXCELLENT:  Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

Other Studies

SCOUT: The purpose of this investigation is to evaluate the safety and effectiveness of the Spineology Interbody Fusion System in an instrumented lumbar interbody fusion

NUVASIVE:
The objective of this study is to validate the utility and effectiveness of comprehensive surgical planning in restoring and preserving sagittal alignment through the collection of clinical and radiographic outcomes

SOLAS:
To create a database of clinical, radiographic, and economic outcome measures of spinal surgery patients to evaluate the efficacy and cost of various procedures for multiple diagnoses

ENRICH:
Early MiNimally-invasive Removal of ICH [ENRICH]

Invest Feasibility/Registry–INVEST:
A single arm, feasibility study of minimally invasive endoscopic surgical treatment with Apollo® or Artemis® system for supratentorial intracerebral hemorrhage (ICH)

RIVER:
 Clinical evaluation of the Serenity River™ Stent System to treat idiopathic intracranial hypertension – The River Trial

 

For more information on clinical trials, contact Jennifer Gay, UBNS Research Study Coordinator, at (716) 929-9643 or jgay@ubns.com.