Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and
responsible for 17,000 deaths. Worldwide, (HCC) is the third leading cause of cancer death.
Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires
repeated treatments and often results in progressively fewer treatment options because of
severe underlying liver dysfunction. While surgery offers the best prognosis for such
tumors and lesions, only 10-15% of all patients are candidates for removal by surgical
means, necessitating the exploration of other treatment options. InnerOptic's AIM Guidance
System is designed to alleviate the difficulty in using ultrasound to place a needle. AIM
shows the needle and the ultrasound slice in their locations in 3D on a stereo monitor,
making the spatial relationship between them obvious. AIM also displays the needle
trajectory and where the needle will intersect with the ultrasound image, providing the
surgeon with an indication of where the needle will go, if inserted along the needle shaft.
AIM can also render an ablation volume guide, providing the surgeon with further
confirmation that the needle is placed accurately and providing a volumetric guide regarding
the power settings of the ablation.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Successful insertion of ablation antenna into target lesion
Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.
Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
John B Martinie
Carolinas Healthcare System
United States: Food and Drug Administration
|Carolinas Health System||Charlotte, North Carolina 28204|