ROBOTIC BIOPSY OF THE UTERUS STANDARDIZED TECHNIQUE – ROBUST

Several studies and a FDA report clearly demonstrate the critical importance of a diagnosis tool allowing to differentiate benign and malignant tumours before a uterine minimally-invasive operation. The problem is, among the numerous diagnostic tools used by clinicians to evaluate women with tumour, none of them have been shown to reliably differentiate a malign from a benign tumour. Since any definitive diagnosis is based on pathologic examination, the gold standard is a uterine biopsy, to distinguish a malignancy from a benign condition, or between two different uterine tumours with different potential evolutions. However, there is no routine tool allowing to conduct sampling in the depth of the uterus.

The ROBUST project gathering an academic laboratory (ISIR), an innovative company (KOELIS) and a hospital (APHP LARIBOISIERE) is intended to provide a solution for this societal issue. The proposed system will exploit state of the art in medical imaging and robotics to provide an innovative system allowing a secure, reproducible, and accurate sampling of the uterine mass. It will include a robotic system to position an ultrasound probe and the needle guide attached to it. A « co-manipulation mode » will be used to control a robotized probe holder. It will allow the surgeon to control the gesture as the robot and the surgeon simultaneously manipulate the ultrasound (US) probe. The gesture will be guided by ultrasound imaging using the latest developments in 3D and 4D reconstructions. In addition, a 3D cartography with accurate sample positions will allow the clinician an efficient interpretation of the biologic analysis of tissues. It will be realized at a TRL7 to be ready for a first-in-human trial at the end of the project.

ROBUST project investigates the scientific aspect of a recent approach for surgical robotics: the development of image based co-manipulated systems. The basic idea is to provide the surgeon with intelligent tools that help him/her only when necessary while letting him/her manipulating the tools. The specific contributions of ROBUST project to this novel diagnosis procedure leads in the following items:

• First, the way of integrating the robot in the procedure is original by itself: the robot is a probe holder and a sensor to locate the probe for image processing.
• Second, image registration between MRI/US volumes and US/US volumes is a challenging research
• Finally, the development of image based guidance for uterus is an open problem.

The competences of the project partners are very complementary and cover every scientific and technical aspect of the project, which should result in a high probability of success. All parts of the project are intimately linked, making ROBUST a fully collaborative project bringing together: an academic laboratory which concern is robotic systems for gesture assistance; a clinical partner having experiences in the field of clinical validation of new technologies and expertise in minimally invasive surgery for gynaecology; a French start-up company specialized in image-guided surgical systems.