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| ID | Type | Description | Link |
|---|---|---|---|
| ASNG-LFNA-101-IL | Other Identifier | Protocol # |
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| Name | Class |
|---|---|
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
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This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSightâ„¢ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration.
Target location will be in the chest area; the procedure will be performed by a trained physician.
Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy 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 the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ActiSightâ„¢ 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiSightâ„¢ Needle Guidance System | Device | 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 adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report | Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images | Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images | 6 month |
| Number of needle punctures through the skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boaz Tiran, Dr. | Tel-Aviv Sourasky Medical Center | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 29, 2013 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 29, 2013 | Yes |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Number of needle punctures through the skin |
| 6 month |
| Number of needle punctures through the pleura | Number of needle punctures through the pleura | 6 month |
| Number of CT scans needed | Number of CT scans needed | 6 month |
| Duration of procedure: patient preparation, planning, guidance and Cytolog report. | Duration of procedure: patient preparation, planning, guidance and Cytolog report. | 6 month |