Radiofrequency Ablation

Researchers are studying a new minimally invasive treatment for breast cancer patients who cannot undergo surgery because of medical reasons or personal choice. This study evaluates a combined cryo-thermal ablation system, a device developed in China that uses both extreme cold and heat to destroy tumor tissue. The goal is to assess the safety and effectiveness of this treatment in patients with early breast cancer who are unsuitable for surgical removal of tumors. The treatment uses a special device that applies deep freezing with liquid nitrogen and high-intensity heating with anhydrous ethanol. This combined approach aims to destroy the breast tumor while reducing complications such as bleeding or tumor spread along the needle path. Patients receive ultrasound-guided ablation of the breast tumor, and the device’s effects are closely monitored during and after treatment. The study follows patients prospectively using a breast disease cohort database, with different groups including those who cannot have surgery due to age or health, those with advanced or metastatic disease, and those refusing surgery. Participants will undergo data collection including imaging tests like ultrasound, mammography, and MRI, plus laboratory and pathology assessments before and after ablation. Follow-up occurs every six months for at least five years, tracking outcomes such as tumor recurrence, disease-free survival, and overall survival. Safety is monitored through reporting of complications within three months after treatment. The primary focus is on local tumor control and complication rates, with additional analysis of immune response and imaging features related to recurrence risk.

Researchers are evaluating microwave ablation (MWA) as a minimally invasive treatment option for patients with relapsed Graves' disease who have previously been treated with anti-thyroid drugs but experienced a return of symptoms. Graves' disease is the most common cause of hyperthyroidism, and conventional treatments include anti-thyroid drugs, radioiodine, and surgery. However, these treatments have drawbacks such as side effects, risk of worsening eye symptoms, or surgical complications, which has led to interest in alternative therapies like MWA. In this study, all participants will receive ultrasound-guided MWA treatment using a device that inserts a microwave antenna into the thyroid gland to apply thermal energy and ablate the tissue. The procedure targets the entire thyroid gland, including both lobes, the isthmus, and the pyramidal lobe. This approach avoids surgical scars and preserves the organ, and it is performed as an outpatient procedure. The study does not involve comparison groups but focuses on evaluating this treatment. During the study, participants will be monitored for remission of Graves' disease six months after the procedure. Researchers will also measure changes in quality of life and thyroid gland volume at six months. The study includes follow-up assessments to evaluate treatment outcomes and safety. Participants can expect clinical evaluations and ultrasound examinations as part of their involvement. The total participation duration extends at least six months post-treatment.

Researchers are evaluating the use of a hybrid cryo-thermal ablation system compared to traditional breast-conserving surgery for women diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer. This prospective, randomized controlled trial aims to assess differences in tumor recurrence, treatment safety, and patient quality of life after these treatments. The study involves patients newly diagnosed and treated at a single center in China using an advanced minimally invasive device combining freezing and heating for tumor destruction. Participants will be randomly assigned to receive either the hybrid cryo-thermal ablation or standard breast-conserving surgery. The ablation procedure includes ultrasound-guided insertion of a probe into the tumor, followed by cycles of freezing and heating to destroy the tumor tissue. The surgery group undergoes breast-conserving surgery following Chinese clinical guidelines to remove the tumor with negative margins. Both treatments intend to fully cover the tumor area, ensuring oncological safety. During the trial, participants will be monitored for surgical details, complications, immune cell changes, and treatment efficacy including local recurrence rates and survival outcomes over several years. Aesthetic results and quality of life will also be evaluated using patient surveys. Imaging and pathological analyses will explore tumor response and potential links between imaging features and recurrence risk. The study includes follow-up assessments and safety evaluations up to five years after treatment to understand long-term outcomes.

Researchers are investigating the mechanisms that sustain persistent atrial fibrillation (AF) and ventricular fibrillation (VF) in humans. This study focuses on understanding how specific areas of high-frequency electrical activity, called DFASI domains, maintain these heart rhythm disorders. The project aims to explore how targeting these domains with ablation therapy affects AF dynamics and clinical outcomes, and to extend these findings to improve treatment options for patients with recurrent VF. The study involves two groups: a control group receiving circumferential pulmonary vein isolation (CPVI) alone, and an active group receiving CPVI plus additional ablation targeting DFASI domains identified through non-invasive mapping. After CPVI in both groups, researchers will perform non-invasive mapping to assess fibrillation patterns, with the active group undergoing sequential ablation of the DFASI domains. Adenosine will be used to evaluate changes in fibrillation dynamics before and after ablation. Participants will undergo detailed non-invasive mapping during the procedure to identify reentrant areas with high activation frequency. Researchers will measure changes in fibrillation dynamics during and after ablation, and track arrhythmia burden over follow-up visits at 3, 6, and 12 months. The study includes safety monitoring and aims to improve understanding of fibrillation physiology and treatment effectiveness over time.

Researchers are investigating the use of ablation combined with lenvatinib and a PD-1 inhibitor for advanced hepatocellular carcinoma (HCC) with oligometastasis. This study explores a subtype of metastatic HCC where there are limited metastases, aiming to evaluate whether removing these metastases can improve survival. The trial is a multicenter, prospective, phase II study focused on the safety and effectiveness of this combined approach. Participants receive a treatment combining ablation of oligometastases using microwave ablation, radiofrequency ablation, or cryoablation, along with systemic therapy using lenvatinib and PD-1 inhibitors. Ablation targets metastases limited to five sites in no more than two organs, each measuring up to 5 cm. Patients must have already received at least 3 months of lenvatinib and PD-1 inhibitor therapy with controlled intrahepatic tumors before ablation. Throughout the study, participants will be monitored for progression-free survival over 24 months as the primary outcome. Additional assessments include overall survival, objective response rate, and adverse events within 12 to 24 months. Researchers will perform regular evaluations to track treatment response and safety, with the total study duration extending to August 2027.

Researchers are investigating the use of ablation combined with systemic therapy for treating advanced hepatocellular carcinoma (HCC) with pulmonary oligometastases. Pulmonary oligometastases represent a stage between localized and widespread disease. While ablation has been effective for intrathoracic metastases from various cancers, its role specifically in HCC with lung oligometastases is still being evaluated. This multicenter retrospective study aims to provide clinical evidence on this treatment approach compared to systemic therapy alone. Participants receive either ablation of pulmonary metastases using image-guided techniques such as microwave ablation, radiofrequency ablation, or cryoablation under CT guidance combined with systemic therapy, or systemic therapy alone following treatment instructions. Ablation targets complete destruction of lung metastases. All participants have already received first-line systemic therapy and may have undergone locoregional treatments like transarterial chemoembolization or hepatic arterial infusion chemotherapy. During the study, researchers will monitor participants for progression-free survival over 12 months as the primary outcome. Secondary outcomes include overall survival at 24 months and objective response rate at 12 months. Participants will be followed with clinical assessments to evaluate tumor control and treatment effects. The study includes adults aged 18 to 80 years with controlled intrahepatic tumors and limited metastatic sites, aiming to understand the benefits and risks of adding ablation to standard systemic therapy in this population.

Researchers are exploring how deep brain nuclei activity and the cerebral cortex function during recovery from general anesthesia in patients undergoing deep brain stimulation (DBS) surgery. This study aims to understand the changes and connections between deep brain nuclei firing and cortical activity during the return of consciousness. The research focuses on the brain's neural networks involved in recovery, which is not just a passive drug clearing process but an active brain function. During the study, patients having DBS surgery will have their local field potentials (LFP) from deep brain nuclei and scalp electroencephalograms (EEG) from the frontal cortex recorded simultaneously. No additional interventions are given beyond the planned DBS surgery. These recordings occur during the recovery period after general anesthesia to analyze how signals from deep brain areas relate to cortical EEG activity. Participants will be monitored for changes in brain signals over about 2 hours during recovery from anesthesia. Researchers will evaluate the number of patients showing changes in LFP and EEG patterns. The study includes assessments of brain activity to better understand consciousness recovery mechanisms. Patients are expected to cooperate during surgery and recording, with the total observation focused on the immediate post-anesthesia recovery phase.

Researchers are evaluating the CellFX nsPFA Cardiac Surgery System for treating atrial fibrillation (AF) in adults undergoing heart surgery. This prospective, multicenter, non-randomized single-arm study focuses on adults aged 18 to 85 with paroxysmal or persistent AF who are scheduled for cardiac surgery involving cardiopulmonary bypass. The goal is to assess the safety and effectiveness of this device during concomitant cardiac surgical procedures. Participants will receive cardiac ablation using the CellFX nsPFA Cardiac Clamp system during their open-heart surgery. The procedure includes isolation of the left and right pulmonary veins and the left atrial posterior wall via roof and floor lesions, forming a box lesion set. Left atrial appendage exclusion or removal is also performed. The left atrial posterior wall isolation can be achieved by either an epicardial lesion or a combined epicardial and endocardial approach when the left atrium is open. During the study, participants will be monitored for freedom from atrial arrhythmias lasting more than 30 seconds and freedom from increased use of certain antiarrhythmic drugs from 3 to 6 months after the procedure. Safety is tracked by recording major adverse events such as death, stroke, heart attack, or bleeding within 30 days after surgery. Follow-up includes assessments of electrical isolation immediately after ablation and patient-reported quality of life at 6 and 12 months. The total participation period includes baseline, procedure, and follow-up visits up to 12 months.

Researchers are evaluating the initial safety and performance of the CellFX nano-second Pulsed Field Ablation (nsPFA) 360 Catheter Endocardial Ablation System for treating atrial fibrillation. This first-in-human, prospective, non-randomized, open-label study aims to assess how well this device works and its safety in patients with paroxysmal atrial fibrillation who have not responded to certain medications. The study is sponsored by Pulse Biosciences, Inc. and focuses on cardiac arrhythmia treatment using a novel ablation technology. The study involves using the CellFX nano-PFA 360 Catheter System, which delivers nanosecond electrical pulses to heart tissue to disrupt abnormal electrical signals causing atrial fibrillation. Subjects will receive the ablation treatment during a cardiac electrophysiology procedure, followed by immediate and 3-month assessments to check the electrical isolation of the pulmonary veins. The system includes the catheter, console, and related accessories designed for this purpose. This is a single treatment arm study without randomization or placebo. Participants will be monitored for up to 12 months after the procedure. They will undergo electroanatomical mapping immediately after ablation and again at 3 months to evaluate treatment success. Researchers will track safety outcomes including major adverse events within 30 days, as well as longer-term adverse events and treatment effectiveness over 12 months. Follow-up visits include clinical examinations and tests to assess heart function and arrhythmia recurrence, ensuring comprehensive monitoring of both safety and device performance.

Researchers are evaluating the initial safety and effectiveness of the CellFX nsPFA Cardiac Clamp in treating atrial fibrillation during cardiac surgery. This feasibility study involves adult patients who need a concurrent cardiac surgical procedure and aims to perform a box lesion around the four pulmonary veins either alone or as part of a larger surgical ablation set. Participants will undergo left pulmonary vein, roof, and floor ablations to create a left atrial posterior box using the CellFX nsPFA Cardiac Surgery System. This is a single-arm, non-randomized study where all subjects receive this treatment during their scheduled cardiac surgery, such as mitral or aortic valve repair, ascending aortic aneurysm repair, or coronary artery bypass. After surgery, participants will return between 60 and 120 days for a cardiac electrophysiology study with electroanatomical mapping to check the electrical isolation of the pulmonary veins and left atrial posterior wall. Researchers will monitor adverse events within 30 days, assess acute electrical isolation within 24 hours, and track long-term technical success up to 12 months. The study involves follow-up visits and various assessments to evaluate safety and performance over time.