Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: prospective 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system |
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.
Other Names:
|
| No Intervention: retrospective 8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 |
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Istituto Clinico Humanitas Rozzano | Milano | MI | Italy | 20089 |
| 2 | IRCCS Ospedale Galeazzi - Sant'Ambrogio | Milano | MI | Italy | 20157 |
Sponsors and Collaborators
- R.A.W. - S.R.L.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESBB1