Trial Outcomes & Findings for Advanced Image Guidance Utilized in Liver Surgery (NCT NCT01666145)
NCT ID: NCT01666145
Last Updated: 2022-04-22
Results Overview
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.
COMPLETED
NA
14 participants
Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
2022-04-22
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advanced Image Guidance Utilized in Liver Surgery
Baseline characteristics by cohort
| Measure |
Intraoperative Imaging
n=14 Participants
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.
|
|---|---|
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Age, Continuous
|
63 years
n=39 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intraoperative Imaging
n=14 Participants
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.
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|---|---|
|
Successful Insertion of Ablation Antenna Into Target Lesion
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100 percentage of participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intraoperative Imaging
n=14 Participants
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.
|
|---|---|
|
Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)
|
100 percentage of participants
|
Adverse Events
Intraoperative Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place