NCT05732558

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: R.A.W. - S.R.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Bone Lesion
• Bone Tumor
• Bone Infection

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2022-12-16
• Primary completion: 2023-03-08
• Completion: 2023-03-08
• First posted: 2023-02-17
• Last updated: 2023-03-09

Locations

1 site across 1 country: Italy