Advanced Image Guidance Utilized in Liver Surgery

Wake Forest University (WFU)

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Device: Advanced Image Guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT01666145

12-11-13B

Details and patient eligibility

About

Advanced Image Guidance for this study was used during laparoscopic microwave ablation surgery to help the surgeon accurately place the ablation needle into the tumor of patients diagnosed with liver cancer.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Intraoperative Imaging

Experimental group

Description:

Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.

Treatment:

Device: Advanced Image Guidance