Biopsies are an integral part of determining a patient’s condition. Just like any other medical treatment, there are risks that can cause patient apprehension, such as bleeding complications and concerns regarding percutaneous needle biopsies (PNB) of solid organs. Ultrasound-guided percutaneous liver and kidney biopsies, for example, while pivotal for diagnosis and staging of hepatic and renal diseases, have been associated with complications such as pain, pneumothorax, bile peritonitis, and, notably, bleeding.
In response to this challenge, a team of researchers has conducted a clinical investigation spanning two countries, which uncovered the safety and efficacy of the Single Pass Kronos Electrocautery Device—a disposable biopsy device designed to mitigate bleeding complications and enhance patient safety during solid organ biopsy procedures.
The study enrolled 60 patients across two continents, aiming to assess the performance of the Kronos Electrocautery Device in reducing or preventing bleeding during liver, kidney, and other solid tissue biopsies. The primary objective was to evaluate optimal withdrawal parameters, ensuring rapid cessation of bleeding and minimal blood loss. The Kronos device, equipped with electrocautery capabilities, was employed to coagulate tissue around the core biopsy channel during withdrawal, potentially revolutionizing the safety and efficacy of biopsy procedures, especially for patients at risk of bleeding complications.
The investigation spanned two sites—one in Riga, Latvia, and the other in Long Beach, California, USA. The study adhered to rigorous ethical and regulatory standards, aligning with ISO 14155:2020, Good Clinical Practice, and the Declaration of Helsinki. The subjects, enrolled after providing informed consent, underwent ultrasound or CT-guided percutaneous biopsies utilizing the Kronos Electrocautery Device to assess its safety, performance, and usability.
Results from the feasibility study yielded promising outcomes. In Latvia, all 30 participants underwent biopsy procedures without any reported adverse events, showcasing the device’s safety and effectiveness in controlling bleeding; similarly, in the US study, which included 30 participants, no clinically relevant bleeding complications were observed during the procedures. Although five adverse events were reported during follow-up, they were assessed as unrelated or unlikely to be related to the biopsy procedure or the use of the Kronos device.
The Kronos Electrocautery Device demonstrated optimal withdrawal parameters, rapid bleeding cessation, and negligible blood loss, with a mean bleeding time of 12 seconds across both study sites. The device’s usability received high ratings from operators, emphasizing its potential to seamlessly integrate into biopsy procedures.
This pioneering device aims to address a critical concern in solid organ biopsies and hopes to offer a potential game-changer in patient safety and procedural efficiency. The reduction of bleeding complications could have far-reaching implications, from minimizing the need for extended patient observation and follow-up imaging to averting potential hospitalization.
While this feasibility study focused on safety and usability, future research may delve into the device’s efficacy in reducing clinically significant hemorrhage post-biopsy. If proven effective, the Kronos Electrocautery Device could usher in a new era in solid tissue biopsy procedures, enabling early patient discharge, safely accommodating coagulopathic patients, and potentially improving sample adequacy.
The Kronos Electrocautery Device represents a significant stride in the field of percutaneous needle biopsies, promising enhanced safety and efficiency. This innovative solution has the potential to redefine the landscape of solid organ biopsy procedures, offering a safer alternative for patients and a more streamlined process for healthcare providers. As research progresses, the Single Pass Kronos device could become a cornerstone in the evolving narrative of biopsy technologies, marking a pivotal moment in patient care and procedural outcomes.
Published by: Martin De Juan