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

NCT ID: NCT01318473

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

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.

Conditions

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Cancer

Keywords

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cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ActiSight™ Needle Guidance System

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.

Group Type OTHER

ActiSight™ Needle Guidance System

Intervention Type DEVICE

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.

Interventions

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ActiSight™ Needle Guidance System

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.

Intervention Type DEVICE

Other Intervention Names

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ActiSight System

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role collaborator

ActiViews Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boaz Tiran, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Other Identifiers

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ASNG-LFNA-101-IL

Identifier Type: OTHER

Identifier Source: secondary_id

ASNG-LFNA-102-IL

Identifier Type: -

Identifier Source: org_study_id