Trial results for the EPIONE Guided Lung Evaluation study, evaluating the EPIONE® device for percutaneous procedures in Lung Cancer, were posted on ClinicalTrials.gov on 2025-07-15, demonstrating a mean needle placement accuracy of 1.2 mm among 25 enrolled participants.
Background
Lung cancer remains a significant health challenge, often requiring precise diagnostic and therapeutic interventions. Percutaneous procedures, such as biopsies or ablations, are crucial for both diagnosing suspicious lesions and treating early-stage tumors. The accuracy and safety of needle placement during these procedures are paramount to ensure effective outcomes and minimize complications. Technologies that enhance precision and reduce the need for multiple adjustments can significantly improve patient care. The EPIONE® device is designed to assist clinicians in performing percutaneous procedures in the lung, aiming to improve the accuracy and efficiency of these critical interventions for lung cancer patients.
Trial design
This completed study, titled "EPIONE Guided Lung Evaluation," enrolled 25 participants with Lung Cancer. The trial was designed to obtain performance and safety data for the EPIONE® device when used for percutaneous procedures in the lung. It was categorized as a Phase NA study, focusing on the interventional use of the device. The study evaluated various performance metrics including feasibility, needle placement accuracy, and ablation success, without a specified comparator arm, focusing solely on the interventional arm using the EPIONE® device.
Key results
The trial results provided several key measurements regarding the performance and safety of the EPIONE® device:
- Feasibility of the Device: A total of 26 targets were reached, indicating the device's ability to access targeted areas.
- Needle Placement Accuracy: The mean needle placement accuracy was 1.2 mm, with a Standard Deviation of 2.1.
- Number of Needle Adjustments: The mean number of adjustments per needle was 0.8, with a Standard Deviation of 0.5.
- Post-intervention Ablation Success: Ablation success was observed in 20 lesions.
- Long-term Efficacy of Ablation: Long-term efficacy was noted in 18 participants.
- Adverse Event: Adverse events were reported in 5 participants.
- Grade of Needle Adjustment: Specific counts for needle adjustments were reported as 7 needle, 17 needle, 1 needle, and 6 needle, likely reflecting different grades or categories of adjustments.
What this means
The results from the EPIONE Guided Lung Evaluation trial suggest that the EPIONE® device can achieve a high degree of precision in percutaneous lung procedures, with a mean needle placement accuracy of 1.2 mm. The device also demonstrated feasibility by successfully reaching 26 targets. The low mean number of needle adjustments (0.8 per needle) indicates efficient targeting. Furthermore, the observed post-intervention ablation success in 20 lesions and long-term efficacy in 18 participants are encouraging for the potential therapeutic application of the device. While adverse events occurred in 5 participants, the overall data points towards the EPIONE® device potentially enhancing the precision and effectiveness of percutaneous interventions for patients with lung cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05651867, titled "EPIONE Guided Lung Evaluation," were posted on 2025-07-15 on clinicaltrials.gov.