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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ActiViews Ltd.
ClinicalTrials.gov Identifier:
NCT01040884
First received: December 29, 2009
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Other: ActiSight Needle Guidance System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ActiViews Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of needle punctures through the skin [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • Number of CT scans needed [ Time Frame: During procedure ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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
Other Names:
  • ActiSensor
  • ActiSticker

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040884

Locations
Israel
ActiViews Ltd
Haifa, Israel
Sponsors and Collaborators
ActiViews Ltd.
Investigators
Principal Investigator: Liat Appelbaum, Dr. Hadassah Ein Carem
  More Information

No publications provided

Responsible Party: ActiViews Ltd.
ClinicalTrials.gov Identifier: NCT01040884     History of Changes
Other Study ID Numbers: ASNG-LFNA-101-IL-H
Study First Received: December 29, 2009
Last Updated: July 10, 2012
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 25, 2014