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

NCT ID: NCT01238653

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Cancer

Keywords

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liver cancer tumor Pathfinder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pathfinder Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David A. Geller, M.D.

Role: PRINCIPAL_INVESTIGATOR

UPMC, Montefiore Hospital Liver Cancer Center

Locations

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UPMC, Montefiore Hospital Liver Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.liversurgery.com

Pathfinder Company Link

Other Identifiers

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PTI-LC-2009-02

Identifier Type: -

Identifier Source: org_study_id