Clinical Trials

Clinical Trials

Clinical Trials

Our clinical evidence helps ensure the optimal use of our therapies for patients around the world.

We have a diverse portfolio of products including medical devices, pharmaceuticals, and drug-device combinations in several therapeutic areas. We continue to invest in clinical trials designed to expand the appropriate uses and geographic availability of our existing products. We also generate data to support bringing innovative new products to market – and to the patients who need them most. We are committed to demonstrating the value of our therapies to patients, physicians, payers and healthcare systems. 
   
In addition to traditional clinical trials, we also invest in the development of Patient Reported Outcome (PRO) measures, Health Economics Outcomes Research (HEOR) and validation of these instruments, Patient Benefit-Risk Preferences for Health Outcomes Studies, and Product Performance Evaluation Studies.

Take a look at our Ongoing Clinical Trials*

Interventional Oncology

Product Clinical Trial Title / Identifier  Trial Type Purpose 
TheraSphere® Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC) NCT01556490 Randomised Control Trial The safety and effectiveness of TheraSphere® will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere®.
TheraSphere® A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy (EPOCH) NCT01483027 Randomised Control Trial The effectiveness and safety of TheraSphere® will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere®.
GALIL™ Cryoablation System Tracking Renal Tumors After Cryoablation Evaluation (TRACE) NCT01117779 Prospective Observational Registry TRACE is an observational, open-label, single-arm, multi-centre registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.
GALIL™ Cryoablation System Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases (MOTION) NCT02511678 Interventional Open- Label Study This study will evaluate the efficacy of cryoablation for palliation of painful metastases in patients with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (e.g. radiation, analgesics).
GALIL™ Cryoablation System Study of Cryoablation for Metastatic Lung Tumors (SOLSTICE) NCT01957787 Interventional Open- Label Study The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in patients with pulmonary metastatic disease. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation procedure.
GALIL™ Cryoablation System Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE) NCT01307501 Interventional Open- Label Study

ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 cm in patients with pulmonary metastatic disease.

vandetanib-eluting radiopaque beads Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies (VEROnA) A pilot, open label single arm phase 0 window of opportunity study

This is a pilot, open label single arm phase 0 window of opportunity study of vandetanib-eluting radiopaque beads in patients with resectable liver malignancies.

 

Interventional Pulmonology

Product  Clinical Trial Title / Identifier  Trial Type  Purpose 
PneumRx® Coil System** Post Market Observational, Prospective, Multi-center Study NCT01806636 Prospective Observational Registry This registry is a post market observational, prospective, multi-centre registry. It is designed to evaluate patient experience with the RePneu™ device for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product. In addition, the registry will collect information that will serve as the foundation for a cost effectiveness analysis.
PneumRx® Coil System**   Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment NCT02499380 Prospective Observational Registry The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu™ Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu™ Coils, when used as intended.
PneumRx® Coil System** Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW) NCT01608490 Randomised Control Trial Multicentre, randomised, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu™ Lung Volume Reduction Coil (RePneu™ LVRC) System
PneumRx® Coil System**   LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER) NCT02059057 Prospective Single Arm Interventional Study Crossover study for patients who were randomised to the Control Group in CLN0009.

 

Interventional Vascular 

Product Clinical Trial Title / Identifier   Trial Type  Purpose 
EKOS® Endovascular System** ACCelerated ThrombolySiS for Post-Thrombotic Syndrome Using EKOS® Interventional Study To evaluate the efficacy of ultrasound accelerated ACCelerated ThrombolySiS for Post-Thrombotic Syndrome Using the EKOS® Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome and chronic venous occlusion.
EKOS® Endovascular System** Study of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in the Treatment of Acute Submassive Pulmonary Embolism (OPTALYSE PE) Interventional Study The objective of the study is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure as a treatment for acute submassive pulmonary embolism.

 
*Table only includes ongoing studies. Studies listed as Completed in Clinicaltrial.gov or EUdraCT are not included. Studies in planning and early start up phases (i.e. not yet in ClinicalTrial.gov or EudraCT) are not included as they may contain sensitive information not yet in public domain. Last updated 19 May 2017.

 ** PneumRx® Coil is also referred to as RePneu™. EKOS® is also referred to as EkoSonic®.

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