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This will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSightâ„¢ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the ActiSightâ„¢ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the ActiSightâ„¢ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ActiSight Needle Guidance System | Experimental | ActiSightâ„¢ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiSight Needle Guidance System | Other | ActiSightâ„¢ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of needle punctures through the skin | During procedure | |
| Number of CT scans needed | During procedure |
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Inclusion Criteria:
Exclusion Criteria:
Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
Use of Aspirin or similar antithrombotic medication
Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
Subjects who cannot tolerate mild sedation
Subjects with the following laboratory values, unless approved by hematologist:
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| Name | Affiliation | Role |
|---|---|---|
| Liat Appelbaum, Dr. | Hadassah Ein Carem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ActiViews Ltd | Haifa | Israel |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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