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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prospective | Experimental | 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system |
|
| retrospective | No Intervention | 8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Total radiation dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Galeazzi - Sant'Ambrogio | Milan | MI | 20157 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37468652 | Derived | Albano D, Messina C, Gitto S, Chianca V, Sconfienza LM. Bone biopsies guided by augmented reality: a pilot study. Eur Radiol Exp. 2023 Jul 20;7(1):40. doi: 10.1186/s41747-023-00353-w. |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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)
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all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)
|
|
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) |
| 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) |
| Side effects | Total number of major+minor side effects, reported during the procedure | During bone biopsy procedure (after the bone sample has been collected) |