Swiss medical device company Compremium has launched its first-in-human clinical study to evaluate a novel non-invasive diagnostic device for thyroid nodules, potentially revolutionizing how clinicians distinguish between benign and malignant thyroid tissue. The study, conducted in collaboration with Bern University Hospital (Inselspital), aims to reduce unnecessary thyroid surgeries by providing more precise diagnostic information for patients with intermediate-risk thyroid nodules.
Addressing a Critical Diagnostic Gap
The clinical trial targets patients with Bethesda IV thyroid nodules, a classification that carries intermediate cancer risk but presents significant diagnostic challenges. Despite cancer rates of only 25% to 40% in this population, many patients undergo surgery as a precaution due to the limitations of current diagnostic methods.
"Patients with an intermediate risk of cancer are currently referred for surgery because fine needle aspiration cannot definitively confirm or exclude a diagnosis of malignancy," said PD Dr. med. Urs Borner, one of the study's principal investigators. "In many cases, these surgeries turn out to have been unnecessary in retrospect. This new technology might help us make more accurate and individualized clinical decisions."
The study's significance is underscored by the prevalence of thyroid nodules, which are detected in up to two-thirds of adults via routine ultrasound, though fewer than 5% are cancerous. This creates a substantial burden of unnecessary procedures for patients with indeterminate findings.
Novel Compressibility-Based Technology
Compremium's CPMX2 system employs a proprietary measurement method that quantifies tissue compressibility, leveraging the principle that malignant nodules tend to be stiffer than benign ones. The device combines ultrasound imaging with pressure sensing to provide real-time visualization of tissue stiffness characteristics.
"This study will help us explore whether measuring the compressibility of thyroid nodules could provide additional information for clinical decision-making," said Prof. Dr. med. Marco Caversaccio, Chief Physician and Clinic Director ENT, Head and Neck Surgery at Bern University Hospital. "By assessing the characteristics of thyroid nodules in real time, we aim to minimize invasive procedures and improve patient care through risk-adapted monitoring."
The technology has already received FDA 510(k) clearance for other applications and has been validated in more than 40 clinical studies, demonstrating promise across over 30 medical indications.
Study Design and Clinical Implementation
The 18-month study will enroll up to 30 adult patients with Bethesda IV thyroid nodules who are already scheduled for surgical removal. These patients will undergo additional compressibility testing with the CPMX2 system, allowing researchers to compare the device's measurements with surgical pathology results.
The multidisciplinary research team is led by Prof. Dr. Marco Caversaccio, PD Dr. Urs Borner, and Dr. Samuel Tschopp, working in cooperation with Prof. Roman Trepp from Endocrinology and Prof. Reto Kaderli from Visceral Surgery. The study is registered in the Human Research Switzerland database.
Broader Implications for Cancer Diagnostics
Vincent Baumann, CEO of Compremium AG, emphasized the potential impact beyond thyroid care: "We're proud to be working with Inselspital on this important project. It will allow us to evaluate whether our technology can address a critical gap in thyroid cancer diagnostics and help reduce the current 75% false-positive rate of Bethesda IV nodules. We believe this approach could fundamentally improve how doctors evaluate tissue health and guide treatment decisions."
If successful, the study could establish the foundation for broader applications of compressibility-based diagnostics in oncology and other medical fields. The company plans further FDA and CE submissions in 2025, potentially expanding the technology's clinical applications.
The device's versatility is demonstrated by its unique operational history, with a prototype having been in use aboard the International Space Station for eight years through a collaboration with NASA, highlighting the technology's robustness and potential for diverse medical applications.
