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Advanced Image Guidance Utilized in Liver Surgery

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ClinicalTrials.gov Identifier: NCT01666145
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : April 1, 2014
Sponsor:
Collaborator:
InnerOptic
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Device: Advanced Image Guidance Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666145


Locations
United States, North Carolina
Carolinas Health System
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
InnerOptic
Investigators
Principal Investigator: David A Iannitti, MD Carolinas Healthcare System

Responsible Party: David Iannitti, Surgeon, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01666145     History of Changes
Other Study ID Numbers: 12-11-13B
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by David Iannitti, Carolinas Healthcare System:
Hepatocellular Cancer
Hepatocellular Carcinoma
Hepatoma
Liver Cancer, Adult
Liver Cell Carcinoma, Adult

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases