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Completed

NCT Number: NCT01040884

Safety And Accuracy Study Of The Actisight™ Needle Guidance System In Patients Undergoing CT-Guided Procedures

This will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ActiViews Ltd

Haifa, Israel

About this study

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects, 18 years of age or older at the time of enrollment
  • Subjects meeting all medical conditions for percutaneous aspiration/biopsy with safe path to lesion
  • INR <1.4
  • Written informed consent to participate in the study
  • Ability to comply with the requirements of the study procedures

Exclusion criteria

  • Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
  • Use of Aspirin or similar antithrombotic medication
  • Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
  • Subjects who cannot tolerate mild sedation
  • Subjects with the following laboratory values, unless approved by hematologist:
  • Platelet count < 60,000/mL
  • APTT > 39 sec or PT > 15 sec, INR > 1.4
  • 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

Treatment and study plan

ActiSight Needle Guidance System

Other

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

Other names: ActiSensor, ActiSticker

Primary outcomes

  1. Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan

    Time frame: During procedure

Secondary outcomes

  1. Number of needle punctures through the skin

    Time frame: During procedure

  2. Number of CT scans needed

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

ActiViews Ltd.

Industry

Registry information

Official study title

A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Aspiration, Biopsy and RF Ablations

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 30, 2009
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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