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.

Study Overview

• Status: Completed
• Conditions: Bone Infection; Bone Tumor; Bone Lesion
• Intervention / Treatment: Procedure: 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mattero Francesco Caruso; Phone Number: +390236740903; Email: mf.caruso@endo-sight.it

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20157
      • IRCCS Ospedale Galeazzi - Sant'Ambrogio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prospective; 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; 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.; Other Names: Bone biopsy; augmented reality; endosight; Bone tumor; Bone Lesion
No Intervention: retrospective; 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?

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)

Collaborators and Investigators

• Sponsor: R.A.W. - S.R.L.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): March 8, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: ESBB1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No