Detection Time and Visibility Rating of Novel OneMark Clip Compared to Standard Ultrasound-Visible Breast Lesions in Human Cadavers

Breast tumor localization is crucial for identifying non-palpable lesions. Traditional preoperative wire-localization has shifted toward wire-free devices. The OneMark system is a novel localization method which utilizes a gelatin-coated fiducial marker embedded with nanoparticles and a unique Doppler system for marker detection that emits an audible signal with a visual overlay. The purpose of this study was to evaluate whether surgical residents can more readily detect the novel OneMark clip compared to standard targets using a cadaver model. Trainees completed surveys and a cadaver lab. Target lesions included standard training targets—stuffed olives with pimentos and ultrasound-visible biopsy clips—as well as novel OneMark clips and OneMark clips embedded in phantom mass lesions made of gelatin wax (Gel OneMark). Residents were timed and subsequently completed a post-session survey to rate lesion visibility and confidence using OneMark technology. Statistical analyses were performed using mixed-effects models. Eleven trainees participated. All target lesions were identified, on average, in less than 45 s with the Gel OneMark found in 31 s, ultrasound-visible clip in 35 s, OneMark clip in 42 s and olive in 44 s. While detection time did not vary significantly by target type, posterior lesions took longer to identify than anterior lesions (52 s vs 24 s, p = 0.004). Visibility ratings were significantly higher for OneMark clips compared to standard clips (p = 0.0001) and almost all participants strongly agreed they could identify OneMark with confidence in any location. Using a cadaver model, surgical trainees were able to identify all target lesions within 45 seconds. While detection time of target lesions varied minimally, visibility rating of the novel OneMark technology with its audio and visual properties was significantly higher than standard breast target lesions.