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.
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
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
16
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.
IRCCS Ospedale Galeazzi - Sant'Ambrogio
Milan, MI, Italy
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)
Time frame: 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)
Time frame: During bone biopsy procedure (after the bone sample has been collected)
endosight accuracy
Distance between the tip of the needle and the center of the target (from 0mm to 10mm)
Time frame: 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)
Time frame: 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)
Time frame: During bone biopsy procedure (after the bone sample has been collected)
Side effects
Total number of major+minor side effects, reported during the procedure
Time frame: During bone biopsy procedure (after the bone sample has been collected)
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