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Advanced Image Guidance Utilized in Liver Surgery

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced Image Guidance
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular Cancer, Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Carolinas Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 7, 2012
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
InnerOptic
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1. Study Identification

Unique Protocol Identification Number
NCT01666145
Brief Title
Advanced Image Guidance Utilized in Liver Surgery
Official Title
Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
InnerOptic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Hepatocellular Cancer, Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative Imaging
Arm Type
Experimental
Arm Description
Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.
Intervention Type
Device
Intervention Name(s)
Advanced Image Guidance
Other Intervention Name(s)
AIM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful Insertion of Ablation Antenna Into Target Lesion
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
Secondary Outcome Measure Information:
Title
Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Iannitti, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Health System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

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Advanced Image Guidance Utilized in Liver Surgery

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