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

NCT01318473 | Completed Phase 4 DMC

• 2 other identifiers: ASNG-LFNA-102-ILASNG-LFNA-101-IL
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

cancer

Outcome Measures

Primary Outcomes (1)

• Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report

  Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report

  6 month

Secondary Outcomes (5)

• Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images

  6 month

• Number of needle punctures through the skin

  6 month

• Number of needle punctures through the pleura

  6 month

• Number of CT scans needed

  6 month

• Duration of procedure: patient preparation, planning, guidance and Cytolog report.

  6 month

Study Arms (1)

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.

Device: ActiSight™ Needle Guidance System

Interventions

ActiSight™ Needle Guidance System DEVICE

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.

Also known as: ActiSight System

ActiSight™ Needle Guidance System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ActiViews Ltd.: lead
• Tel-Aviv Sourasky Medical Center: collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Boaz Tiran, Dr.

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: June 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 3, 2012

Record last verified: 2012-10