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


N/A
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The number of accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures

Outcome Description:

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.

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

David A. Geller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UPMC, Montefiore Hospital Liver Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

PTI-LC-2009-02

NCT ID:

NCT01238653

Start Date:

November 2010

Completion Date:

July 2012

Related Keywords:

  • Liver Cancer
  • liver
  • cancer
  • tumor
  • Pathfinder
  • Liver Neoplasms

Name

Location

UPMC, Montefiore Hospital Liver Cancer Center Pittsburg, Pennsylvania  15213