Carcinoma, Hepatocellular
Conditions
Keywords
Hepatocellular Cancer, Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Adult
Brief summary
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.
Detailed 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.
Interventions
DEVICEAdvanced Image Guidance
Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.
Sponsors
InnerOptic
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Insertion of Ablation Antenna Into Target Lesion | Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM) | Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days. | A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative Imaging Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.
Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Intraoperative Imaging |
|---|---|
| Age, Continuous | 63 years |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative Imaging | Successful Insertion of Ablation Antenna Into Target Lesion | 100 percentage of participants |
Secondary
Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)
A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative Imaging | Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM) | 100 percentage of participants |