Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
NCT ID: NCT01286428
Last Updated: 2012-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
30 participants
OBSERVATIONAL
2011-01-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Minimally Invasive Image-Guided Surgery System for Hepatic Ablation Procedures
NCT01238666
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
NCT01237990
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
NCT01238653
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
NCT02243384
Advanced Image Guidance Utilized in Liver Surgery
NCT01666145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Had a preoperative CT image that includes the liver
Exclusion Criteria
* Kidney failure or dialysis
* Unable to consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pathfinder Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David A. Gerber, M.D.
Role: PRINCIPAL_INVESTIGATOR
UNC Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UNC - CH Department of Surgery
Chapel Hill, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Pathfinder Company Link
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PTI-LC-2010-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.