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

NCT01286428 | Completed DMC

• 1 other identifier: PTI-LC-2010-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Keywords

liver; cancer; tumor; ablation; Pathfinder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 Days

• Phase II: The number of surgical oblation procedures that present data showing equivalent location of the ablation probe when compared to the US and Pathfinder Guidance System 3D image data.

  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.

  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 liver ablation 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)

UNC - CH Department of Surgery

Chapel Hill, North Carolina, 27599-7211, 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. Gerber, M.D.

  UNC 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: January 27, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

US (1)