Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy

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

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-06-30

Brief Summary

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This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.

Detailed Description

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Conditions

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Biopsy

Keywords

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Biopsy Fine needle aspiration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Biopsy needle guidance system (ActiSight™)

The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.

Intervention Type DEVICE

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 chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
* Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
* INR \<1.3
* Written informed consent to participate in the study
* Ability to comply with the requirements of the study procedures

Exclusion Criteria

* Fibrous tissue or cyst in access path (not including target lesion)
* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
* Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
* The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
* Use of ticlopidine or similar antithrombotic medication
* For subjects taking warfarin or other anticoagulant medication, INR \>1.3
* Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
* Subjects who cannot tolerate mild sedation
* Subjects with FEV1 \< 800 mL unless approved by principal investigator following consultation with multidisciplinary team
* Subjects with the following laboratory values, unless approved by hematologist:

* Platelet count \<100,000/mL
* APTT \>39 sec or PT \>15 sec
* Pregnancy or lactation
* Patient is unable to comply with requirements of the procedure, i.e. holding breath
* Participation in an investigational trial within 30 days of enrollment
* Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering 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

Responsible Party

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Activiews

Principal Investigators

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Boaz Tiran, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ASNG-LFNA-101-IL

Identifier Type: -

Identifier Source: org_study_id