Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.

In this study results obtained in the prospective group will be compared with those obtained in the retrospective group. Total N° of patients: 16 PROSPECTIVE GROUP (treated WITH the guidance of endosight): N° of patients: 8 RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight): N° of patients: 8 Main objective of the study: Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans. N°of hospitals involved: 2. Duration: maximum 6 months from the date of the first enrollment. No follow-up is expected.

The study is designed to compare a prospective arm composed of 8 patients who were prescribed a CT-Guided bone biopsy (with the aid of endosight navigation system) with a retrospective arm with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 (without endosight navigation system)

all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)

8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022

8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

The study is based on a comparison of the number of CT scans required for needle placement in bone biopsies (trunk area) performed with augmented reality navigation system (endosight) and without.

Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection)

Change in overall number of CT scans performed during the procedure (calculated as the total number of CT scans required to reach the target; from the 1° CT-scan (local anesthesia) to the last CT-scan (sample collection from the bone)

Change in the total radiant dose received by the patient (calculated by summing the radiation emitted for each CT-Scan performed from the anesthesia-point to the collection-point)

Inclusion Criteria: Patient with a bone lesion for which a percutaneous biopsy is indicated; Informed consent signed by the patient for participation in the study. Exclusion Criteria: Age < 18 years; Pregnant and lactating women (assessed through auto declaration of the patient)