Advanced Image Guidance Utilized in Liver Surgery

This study has been completed.
Sponsor:
Collaborator:
InnerOptic
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01666145
First received: May 7, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Carcinoma, Hepatocellular
Device: Advanced Image Guidance

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: David Iannitti, Surgeon, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01666145     History of Changes
Other Study ID Numbers: 12-11-13B
Study First Received: May 7, 2012
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014