Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Lesion
- Sponsor
- R.A.W. - S.R.L.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Procedure time
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Procedure time
Time Frame: 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
Time Frame: 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 Outcomes
- endosight accuracy(During bone biopsy procedure (after the bone sample has been collected))
- Total radiation dose(During bone biopsy procedure (after the bone sample has been collected))
- Operator satisfaction(During bone biopsy procedure (after the bone sample has been collected))
- Side effects(During bone biopsy procedure (after the bone sample has been collected))