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

NCT01238653 | Terminated DMC

• 1 other identifier: PTI-LC-2009-02
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer

Keywords

liver; cancer; tumor; Pathfinder

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any subject scheduled for a laparoscopic procedure where liver surface visualization and surface swabbing is feasible with standard port placement.

You may qualify if:

• Scheduled for laparoscopic procedure
• Had a preoperative CT image that includes the liver

You may not qualify if:

• Severe cirrhosis of the liver
• Kidney failure or dialysis
• Unable to consent

Sponsors & Collaborators

• Pathfinder Therapeutics: lead

Study Sites (1)

UPMC, Montefiore Hospital Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Pathfinder Company Link

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• David A. Geller, M.D.

  UPMC, Montefiore Hospital Liver Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

US (1)