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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238653
• Other study ID #: PTI-LC-2009-02
• Status: Terminated
• Phase: N/A
• First received: November 8, 2010
• Last updated: August 7, 2012
• Start date: November 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Pathfinder Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cancer

Locations

Country	Name	City	State
United States	UPMC, Montefiore Hospital Liver Cancer Center	Pittsburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pathfinder Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open 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.	30 days	No