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Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures

NCT ID: NCT01148706

Last Updated: 2012-12-11

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-09-30

Brief Summary

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To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.

Detailed Description

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The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obstacle free path to a target lesion based on pre-procedure CT images, and then provides real-time information for guiding the interventional tool towards the target along the selected path.

The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.

The primary objective of this study is to demonstrate the effectiveness of the ActiSight™ Needle Guidance System in assisting in CT-guided percutaneous procedures.

Conditions

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Lung Diseases Liver Diseases

Keywords

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thorax abdomen

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

Group Type EXPERIMENTAL

ActiSight Needle Guidance System

Intervention Type DEVICE

The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.

Interventions

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ActiSight Needle Guidance System

The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.

Intervention Type DEVICE

Other Intervention Names

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ASNG=ActiSight Needle Guidance 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 meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.

Exclusion Criteria

* Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
* Significant coagulopathy that cannot be adequately corrected.
* Patients who have a medical contraindication to sedation (Lidocaine allergy).
* Pregnancy or lactation.
* Participation in an investigational trial within 30 days of enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ActiViews Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natan Peled, Dr.

Role: PRINCIPAL_INVESTIGATOR

Carmel MC

Locations

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Carmel Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ASNG-LFNA-103-IL

Identifier Type: -

Identifier Source: org_study_id