Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
| Tracking Information | |||||
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| First Received Date ICMJE | November 8, 2010 | ||||
| Last Updated Date | August 7, 2012 | ||||
| Start Date ICMJE | November 2010 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The number of accurate liver surface registrations obtained in the laparoscopic environment compared to accurate liver surface registrations obtained in open procedures [ Time Frame: 30 days ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01238653 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures | ||||
| Official Title ICMJE | Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures | ||||
| 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. |
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| Detailed 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Liver Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01238653 | ||||
| Other Study ID Numbers ICMJE | PTI-LC-2009-02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pathfinder Therapeutics | ||||
| Study Sponsor ICMJE | Pathfinder Therapeutics | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pathfinder Therapeutics | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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