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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

November 8, 2010
August 7, 2012
November 2010
July 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01238653 on ClinicalTrials.gov Archive Site
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Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Any subject scheduled for a laparoscopic procedure where liver surface visualization and surface swabbing is feasible with standard port placement.

Liver Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01238653
PTI-LC-2009-02
Yes
Pathfinder Therapeutics
Pathfinder Therapeutics
Not Provided
Principal Investigator: David A. Geller, M.D. UPMC, Montefiore Hospital Liver Cancer Center
Pathfinder Therapeutics
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP