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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

Thank you

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 30 subjects: 10 in Phase I and 20 in Phase II that
complete the laparoscopic procedure scheduled.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

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 evaluated and accepted by the surgeon during the procedure.

Outcome Time Frame:

30 Days

Safety Issue:

No

Principal Investigator

David A. Gerber, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

PTI-LC-2010-02

NCT ID:

NCT01286428

Start Date:

January 2011

Completion Date:

March 2012

Related Keywords:

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

Name

Location
UNC - CH Department of Surgery Chapel Hill, North Carolina  27599-7211