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

Bone Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732558
• Other study ID #: ESBB1
• Status: Completed
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: R.A.W. - S.R.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Infection
• Bone Lesion
• Bone Neoplasms
• Bone Tumor

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Galeazzi - Sant'Ambrogio	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
R.A.W. - S.R.L.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Side effects	Total number of major+minor side effects, reported during the procedure	During bone biopsy procedure (after the bone sample has been collected)