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

R.A.W. Srl

Status: Completed

Conditions: Bone Tumor; Bone Lesion; Bone Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05732558

ESBB1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

prospective

Experimental group

Description:

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

Treatment:

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

retrospective

No Intervention group

Description:

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