Advanced Image Guidance Utilized in Liver Surgery
|ClinicalTrials.gov Identifier: NCT01666145|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : April 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Device: Advanced Image Guidance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||February 2014|
Experimental: Intraoperative Imaging
Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.
Device: 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.
Other Name: AIM
- Successful insertion of ablation antenna into target lesion [ Time Frame: 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.
- Ease of lesion targeting using Advanced Image Guidance (AIM) [ Time Frame: 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. In addition, the time to insertion of the probe to lesion targeting in seconds will be recorded for each attempted targeting.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666145
|United States, North Carolina|
|Carolinas Health System|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||David A Iannitti, MD||Carolinas Healthcare System|