The Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided With Lesions Smaller Than 15 mm

Study Overview
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Brief Summary
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This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ 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.

Detailed Description
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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 ActiSight™ 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.

Official Title
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A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm

Conditions
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Cancer

Intervention / Treatment
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* Device: ActiSight™ Needle Guidance System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 18 years of age or older at the time of enrollment Subjects scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures Subjects with lung lesions less than 15 mm. Written informed consent to participate in the study Ability to comply with the requirements of the study procedures Exclusion Criteria: Subjects who cannot tolerate mild sedation Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study. Subjects who are uncooperative or cannot follow instructions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ActiSight™ Needle Guidance System<br>ActiSight™ 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. | Device: ActiSight™ Needle Guidance System<br>* ActiSight™ 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.<br>* Other names: ActiSight System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer