Clinical Trials
22
8 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
3
13.6%
Completed
8
36.4%
Not yet recruiting
5
22.7%
Recruiting
3
13.6%
Terminated
2
9.1%
Withdrawn
1
4.5%
No approval data available
- AngioDynamics has enrolled the first patient in the AMBITION BTK randomized controlled trial, investigating the Auryon Atherectomy System combined with balloon angioplasty versus balloon angioplasty alone for below-the-knee critical limb ischemia. - The trial will include up to 224 patients at 30 sites, with a companion registry enrolling up to 1,500 additional patients, addressing a critical need as untreated CLI carries a 20-25% risk of limb loss at one year. - The Auryon laser system uses 355nm wavelength solid-state technology to treat arterial occlusions and has already been used in over 100,000 patients worldwide, offering potential improvements for challenging below-the-knee lesions. - The study addresses a significant clinical gap, as infrapopliteal disease affects over 70% of CLI patients, particularly in the diabetic population, with limited current treatment options beyond balloon angioplasty.
- The PRESERVE trial demonstrated that irreversible electroporation with the NanoKnife System achieved a 71% negative in-field biopsy rate at 12 months in patients with intermediate-risk prostate cancer. - The treatment preserved quality of life outcomes, with 96% of patients remaining pad-free and 84% of patients with good baseline sexual function maintaining erections sufficient for penetration at 12 months. - The FDA granted 510(k) clearance for the NanoKnife System for prostate tissue ablation in December 2024 based on these trial results. - The non-thermal ablation technology offers a minimally invasive alternative to traditional whole-gland therapies while maintaining strong safety profile with most adverse events being grade 1-2.
- Piccolo Medical has received FDA 510(k) clearance for its second-generation SmartPICC Stylet and PM2+ System, marking a significant advancement in peripherally inserted central catheter placement technology. - The SmartPICC technology provides real-time bedside catheter tip confirmation using cardiac electrical activity, eliminating the need for confirmatory chest X-rays and reducing patient care delays. - The system incorporates proprietary ionic dilution technology for PICC navigation, offering clinicians real-time guidance during catheter insertion and immediate detection of improper vascular advancements. - Piccolo Medical has partnered with Spectrum Vascular as the exclusive North American distributor to commercialize this comprehensive vascular access solution.
- AngioDynamics has enrolled the first patient in the RECOVER-AV clinical trial, evaluating the AlphaVac F1885 System for treating intermediate-risk pulmonary embolism across multiple international sites. - The multi-center study will assess safety and long-term functional outcomes in up to 20 hospital sites across Europe, Canada, and Hong Kong, following patients for 12 months with comprehensive cardiac assessments. - The trial builds on the device's existing FDA 510(k) clearance and CE Mark approval, aiming to generate evidence for broader global adoption of mechanical thrombectomy treatment. - Pulmonary embolism affects approximately 435,000 patients annually in the six largest EU countries, representing a significant unmet medical need for effective treatment options.
- AngioDynamics initiates the AMBITION BTK randomized controlled trial and registry to assess the Auryon laser atherectomy system's effectiveness in treating below-the-knee lesions in critical limb ischemia patients. - The trial builds upon previous successful outcomes from a multicenter study that treated 61 complex calcified lesions in 60 patients, demonstrating strong clinical results with minimal complications. - The Auryon system utilizes innovative 355nm wavelength laser technology that enables targeted treatment of various lesion types while minimizing perforation risks and avoiding thermal ablation.
- AngioDynamics has received FDA clearance for its NanoKnife System for prostate tissue ablation, marking a significant advancement in minimally invasive cancer treatment. - The PRESERVE clinical study demonstrated that 84% of men were free from clinically significant prostate cancer 12 months post-procedure using the NanoKnife System. - The study also showed strong quality of life outcomes, with urinary continence preserved in 95.4% of patients and minimal impact on erectile function. - The NanoKnife System offers a non-thermal, radiation-free alternative to traditional treatments, potentially reducing complications and improving patient quality of life.
- AngioDynamics and UCLH have initiated a prospective registry study to assess the long-term efficacy and safety of the NanoKnife system in treating intermediate-risk prostate cancer. - The NanoKnife system utilizes irreversible electroporation (IRE) to induce controlled cell death in tumors while minimizing damage to surrounding healthy tissues. - The study aims to enroll 500 patients globally, tracking outcomes to validate NanoKnife's effectiveness in reducing the need for radical interventions and preserving patient quality of life. - UCLH, the first UK NHS facility to use NanoKnife, will leverage the registry to refine treatment protocols and standardize patient selection for improved outcomes.
- AngioDynamics has initiated the RECOVER-AV trial to assess the AlphaVac F1885 System's safety and efficacy in treating acute, intermediate-risk pulmonary embolism (PE). - The multi-center, multi-national trial will enroll patients across Europe, evaluating the reduction in right ventricular/left ventricular (RV/LV) ratio post-procedure. - The study follows the APEX-AV trial in the U.S., which demonstrated the AlphaVac system's safety and effectiveness in improving right ventricular function and reducing clot burden. - The AlphaVac F1885 System received CE Mark approval in Europe, allowing AngioDynamics to expand its reach in treating PE, where prevalence is higher than in the U.S.
