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

This study has been terminated.
(Slow enrollment with limited population for study parameters.)
Sponsor:
Information provided by (Responsible Party):
Pathfinder Therapeutics
ClinicalTrials.gov Identifier:
NCT01238653
First received: November 8, 2010
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

This study was 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 procedure. The hypothesis is that there will be no clinically relevant difference between the error measurements obtained during the laparoscopic procedures in this study when compared with those obtained during previous open liver registration studies.

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.


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 Procedures

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Pathfinder Therapeutics:

Primary Outcome Measures:
  • The number of accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures [ 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 compared with open liver registrations obtained from previous validation studies during open liver procedures.



Enrollment: 8
Study Start Date: November 2010
Study Completion Date: July 2012
Primary Completion Date: July 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 20 subjects 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 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: NCT01238653

Locations
United States, Pennsylvania
UPMC, Montefiore Hospital Liver Cancer Center
Pittsburg, Pennsylvania, United States, 15213
Sponsors and Collaborators
Pathfinder Therapeutics
Investigators
Principal Investigator: David A. Geller, M.D. UPMC, Montefiore Hospital Liver Cancer Center
  More Information

Additional Information:
Pathfinder Company Link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pathfinder Therapeutics
ClinicalTrials.gov Identifier: NCT01238653     History of Changes
Other Study ID Numbers: PTI-LC-2009-02
Study First Received: November 8, 2010
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pathfinder Therapeutics:
liver
cancer
tumor
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 June 17, 2013