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Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study

18 Years
Open (Enrolling by invite only)
Carcinoma, Hepatocellular

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Trial Information

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.

Inclusion Criteria:

- Individuals who have hepatocellular carcinoma.

- Individuals who are candidates for microwave ablation surgery.

Exclusion Criteria:

- Individuals who do not have hepatocellular carcinoma.

- Individuals who are not a candidate for laparoscopic microwave ablation surgery.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful insertion of ablation antenna into target lesion

Outcome Description:

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.

Outcome Time Frame:

Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.

Safety Issue:


Principal Investigator

John B Martinie

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carolinas Healthcare System


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • Hepatocellular Cancer
  • Hepatocellular Carcinoma
  • Hepatoma
  • Liver Cancer, Adult
  • Liver Cell Carcinoma, Adult
  • Carcinoma
  • Carcinoma, Hepatocellular



Carolinas Health SystemCharlotte, North Carolina  28204