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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pathfinder Therapeutics
ClinicalTrials.gov Identifier:
NCT01238666
First received: November 9, 2010
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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
Liver Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Ablation Procedures

Resource links provided by NLM:


Further study details as provided by Pathfinder Therapeutics:

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

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238666

Locations
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Pathfinder Therapeutics
Investigators
Principal Investigator: Paul Hansen, M.D. PPMC, Liver Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Pathfinder Therapeutics
ClinicalTrials.gov Identifier: NCT01238666     History of Changes
Other Study ID Numbers: PTI-LC-2010-01
Study First Received: November 9, 2010
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pathfinder Therapeutics:
liver
cancer
tumor
ablation
Pathfinder

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

ClinicalTrials.gov processed this record on April 21, 2014