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This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Additionally, registrations will be obtained with full insufflation pressure and with half insufflation pressure during the laparoscopic procedure. Under the presence of both insufflation pressures, 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 3D image. The surgeon will accept or reject the registration accuracy. Upon completion of the scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled for the surgical case. An open liver registration will be obtained with manual swabbing of the liver using the study tracked probe and will be accepted or rejected by the surgeon using the process described in the laparoscopic procedure.
In the event that the disease is determined to be too great for surgical repair during the laparoscopic staging procedure, only minimally invasive liver surface data will be acquired and the patient will not be included in the overall study population.
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 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.
For the purposes of the study, subjects will be enrolled following the inclusion/exclusion criteria below:
Inclusion:
Exclusion:
A total study population will include 20 subjects that complete both the laparoscopic and open liver procedures scheduled.
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| Measure | Description | Time Frame |
|---|---|---|
| The number of accepted liver registrations associated with laparoscopically acquired surface data compared with the number of accepted liver registrations associated with open liver acquired surface data. | Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of registration errors from the full and half sufflation pressures to determine an impact of insufflation pressure on registration accuracy. | Subjects are followed for the study up to 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Any subject with liver cancer scheduled for a laparoscopic staging and open liver resection procedure.
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| Name | Affiliation | Role |
|---|---|---|
| William Jarnagin, M.D. | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Pathfinder Company Link | View source |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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