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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318473
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : October 3, 2012
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
ActiViews Ltd.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Device: ActiSight™ Needle Guidance System Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
Study Start Date : June 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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.
Device: 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 Name: ActiSight System




Primary Outcome Measures :
  1. Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report [ Time Frame: 6 month ]
    Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report


Secondary Outcome Measures :
  1. Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images [ Time Frame: 6 month ]
    Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images

  2. Number of needle punctures through the skin [ Time Frame: 6 month ]
    Number of needle punctures through the skin

  3. Number of needle punctures through the pleura [ Time Frame: 6 month ]
    Number of needle punctures through the pleura

  4. Number of CT scans needed [ Time Frame: 6 month ]
    Number of CT scans needed

  5. Duration of procedure: patient preparation, planning, guidance and Cytolog report. [ Time Frame: 6 month ]
    Duration of procedure: patient preparation, planning, guidance and Cytolog report.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318473


Sponsors and Collaborators
ActiViews Ltd.
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Boaz Tiran, Dr. Tel-Aviv Sourasky Medical Center
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Responsible Party: ActiViews Ltd.
ClinicalTrials.gov Identifier: NCT01318473    
Other Study ID Numbers: ASNG-LFNA-102-IL
ASNG-LFNA-101-IL ( Other Identifier: Protocol # )
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012
Keywords provided by ActiViews Ltd.:
cancer