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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bone Lesion, Bone Tumor, Bone Infection

Intervention / Treatment
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* Procedure: 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prospective<br>8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system | Procedure: 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system<br>* 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.<br>* Other names: Bone Lesion;|
| No Intervention: retrospective<br>8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection) | During bone biopsy procedure (after the bone sample has been collected) | 
| Total number of CT-SCAN | 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) | During bone biopsy procedure (after the bone sample has been collected) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endosight accuracy | Distance between the tip of the needle and the center of the target (from 0mm to 10mm) | During bone biopsy procedure (after the bone sample has been collected) | 
| Total radiation dose | 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) | During bone biopsy procedure (after the bone sample has been collected) | 
| Operator satisfaction | satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction) | During bone biopsy procedure (after the bone sample has been collected) | 
| Side effects | Total number of major+minor side effects, reported during the procedure | During bone biopsy procedure (after the bone sample has been collected) |