Bone Infection, Bone Lesion, Bone Tumor
Conditions
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.
Interventions
PROCEDURE8 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.
Sponsors
R.A.W. - S.R.L.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)
Intervention model description
The study is designed to compare a prospective arm composed of 8 patients who were prescribed a CT-Guided bone biopsy (with the aid of endosight navigation system) with a retrospective arm with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 (without endosight navigation system)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed