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

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ClinicalTrials.gov Identifier: NCT01238653
Recruitment Status : Terminated (Slow enrollment with limited population for study parameters.)
First Posted : November 10, 2010
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pathfinder Therapeutics

Brief Summary:

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 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 20 subjects that complete the laparoscopic procedure scheduled.


Study Type : Observational
Actual Enrollment : 8 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 : November 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. 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 ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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

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): 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

Responsible Party: Pathfinder Therapeutics
ClinicalTrials.gov Identifier: NCT01238653     History of Changes
Other Study ID Numbers: PTI-LC-2009-02
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

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