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

Not Applicable

Completed

• Conditions: Bone Infection; Bone Tumor; Bone Lesion

• Registration Number: NCT05732558
• Lead Sponsor: R.A.W. - S.R.L.

Brief 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.

Study Timeline

• Study Start: 2022-12-16
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-17
• Status Verified: 2023-03
• Primary Completion: 2023-03-08
• Study Completion: 2023-03-08
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Ospedale Galeazzi - Sant'Ambrogio; 🇮🇹 Milano, MI, Italy