Registries

The Focused Ultrasound Foundation has long championed the importance of clinical data registries in today’s rapidly evolving therapeutic landscape. The value that clinical registries offer is multifaceted and critical to advancing patient care and medical understanding in the following ways: evaluating longitudinal outcomes, defining, and evaluating best practices, developing treatment guidelines, and furthering research and therapeutic development. Below is a compiled list of registries for focused ultrasound.

For more on this topic, please read “Clinical Registries to Evaluate Focused Ultrasound Therapies: A Detailed Examination” by Rick Hamilton, the Foundation’s managing director and chief technology officer.

Focused Ultrasound Registries

• Ultrasound ablation of uterine fibroids: A Prospective, Multicenter, Non-randomized, Parallel controlled study
• A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
• Pediatric Focused Ultrasound Computational Data Center and Registry
• Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
• Multimodel Magnetic Resonance Imaging Study of Essential Tremor and Parkinson Disease (Retrospective)
• ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR – an InternAtional RegistrY
• Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy
• Customized TULSA-PRO Ablation Registry (CARE)
• A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson’s Disease
• Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
• A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson’s Disease With Medication-refractory Moderate to Severe Motor Complications
• HEAT Registry: Evaluating Sonablate® Clinical Data – High-Intensity Focused Ultrasound Evaluation and Assessment of Treatment Registry
• Registry for the Advancement of Deep Brain Stimulation Therapy in Parkinson’s Disease
• FoR-UsA Registry: Focal Robotic Ultrasound Ablation Registry
• EU/CE – define best practice for treatments; quality of life; location/size/shape of lesion – 8 sites in EU (have 4 activated; working on additional 2); promote use of technology; standardization; reimbursement

Please note, is not an exhaustive list. If you are aware of additional focused ultrasound registries, please contact us with this information at registry@fusfoundation.org.

Contract Research Organizations

Contract Research Organizations (CROs) can provide comprehensive services to advance, streamline, and accelerate the path to approval and support registries. The Foundation has compiled a list of full-service CROs with device and registry experience. This is not an endorsement of these organizations; however, it may help narrow the search for full-service providers with the experience needed to accomplish the goals of a focused ultrasound registry.

• Avania
• CMIC Holdings Co., Ltd
• Criterium
• CTI Clinical Trial and Consulting Services
• Eclevar
• Ethica CRO
• Fortrea
• ICON
• IQVIA
• MCRA
• NAMSA
• Navitas Clinical Research
• Parexel
• PPD

Please note, this is not an exhaustive list. If you are aware of additional full-service CROs with device and registry experience, please contact us with this information at registry@fusfoundation.org.