Trial record 2 of 24 for:    pathfinder

Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures

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. Identifier: NCT01286428
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):
Pathfinder Therapeutics

Brief Summary:

This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure.

The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy.

The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study.

Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image.

The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder.

Condition or disease
Liver Cancer

Detailed Description:

The Pathfinder System used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system.

Preoperative computed tomography (CT) scans, obtained as standard of care, will be used to generate the image guided liver system 3D liver surface images used during the study.

During the laparoscopic procedure, the Pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.

A total study population will include 30 subjects: 10 in Phase I and 20 in Phase II that complete the laparoscopic procedure scheduled.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
Study Start Date : January 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Primary Outcome Measures :
  1. Phase I: The number of accurate liver surface registrations obtained in the laparoscopic environment providing the surgeon with a comfort level of adding the registration procedure to the scheduled laparoscopic surgical ablation procedure. [ Time Frame: 30 Days ]

    Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit.

    The performance of accurate physical-to-image registrations obtained during laparoscopic procedures will be evaluated and accepted by the surgeon during the procedure.

  2. Phase II: The number of surgical oblation procedures that present data showing equivalent location of the ablation probe when compared to the US and Pathfinder Guidance System 3D image data. [ Time Frame: 30 Days ]
    The correlation of location of the ablation probe will be evaluated comparing data obtained from the interoperative US images and the data collected with the Pathfinder image guided system.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any subject scheduled for a laparoscopic procedure where liver surface visualization and surface swabbing is feasible with standard port placement.

Inclusion Criteria:

  • Scheduled for laparoscopic liver ablation procedure
  • Had a preoperative CT image that includes the liver

Exclusion Criteria:

  • Severe cirrhosis of the liver
  • Kidney failure or dialysis
  • Unable to consent

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 identifier (NCT number): NCT01286428

United States, North Carolina
UNC - CH Department of Surgery
Chapel Hill, North Carolina, United States, 27599-7211
Sponsors and Collaborators
Pathfinder Therapeutics
Principal Investigator: David A. Gerber, M.D. UNC Cancer Center

Responsible Party: Pathfinder Therapeutics Identifier: NCT01286428     History of Changes
Other Study ID Numbers: PTI-LC-2010-02
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012

Keywords provided by Pathfinder Therapeutics:

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases