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Liver Extracts

Paul Hansen, M.D.

This study was designed in two phases: Phase I is 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 ablation procedure and acquires a level of comfort with the procedure.

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 hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study.

Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image.

The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder.

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.

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

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

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.

The correlation of location of the ablation probe will be evaluated comparing data obtained from the interoperative US images and the data collected with the Pathfinder image guided system.

Pathfinder Therapeutics

David Geller, M.D.

William Jarnagin, MD

Alan Hemming, M.D.

Image-guided surgery essentially describes the interactive use of medical images during a surgical procedure and is often referred to as a "global positioning" system (GPS) for surgery.

In an automobile GPS, the current position of a vehicle is accurately localized or "registered" onto an electronic roadmap located on the dashboard. As the automobile moves, its position is updated on this roadmap. The driver can use the GPS as a guide to determine where the vehicle has been and where it is headed. This same concept is applied during image-guided surgery, as the current surgical position of instruments in the operating room is registered onto medical images of the patient acquired preoperatively. These images are used as a guide by the surgeon for more accurate localization of tumors and other surrounding anatomic structures. This clinical trial is designed to determine the effectiveness of using image-guided techniques for the treatment of liver tumors.

Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer

National Institutes of Health (NIH)

Medelis Inc.

David A. Geller, M.D.

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.

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

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.

Spots Global Cancer Trial Database for pathfinder

Every month we try and update this database with for pathfinder cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Eligibility	Organization
Evaluation of a Minimally Invasive Image-Guided Surgery System for Hepatic Ablation Procedures	NCT01238666	Liver Cancer	18 Years -	Pathfinder Therapeutics
Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer	NCT00782886	Liver Cancer	18 Years -	Pathfinder Therapeutics
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures	NCT01238653	Liver Cancer	18 Years -	Pathfinder Therapeutics
Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer	NCT00782886	Liver Cancer	18 Years -	Pathfinder Therapeutics
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures	NCT01286428	Liver Cancer	18 Years -	Pathfinder Therapeutics
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures	NCT01286428	Liver Cancer	18 Years -	Pathfinder Therapeutics

Spots Global Cancer Trial Database for pathfinder

Every month we try and update this database with for pathfinder cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pathfinder cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.