Advanced Image Guidance Utilized in Liver Surgery

NCT01666145 | Completed Results DMC

• 1 other identifier: 12-11-13B
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Cancer; Hepatocellular Carcinoma; Hepatoma; Liver Cancer, Adult; Liver Cell Carcinoma, Adult

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.

Secondary Outcomes (1)

• Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)

  Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.

Study Arms (1)

Intraoperative Imaging

EXPERIMENTAL

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

Device: Advanced Image Guidance

Interventions

Advanced Image Guidance DEVICE

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.

Also known as: AIM

Intraoperative Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have hepatocellular carcinoma.
• Individuals who are candidates for microwave ablation surgery.

You may not qualify if:

• Individuals who do not have hepatocellular carcinoma.
• Individuals who are not a candidate for laparoscopic microwave ablation surgery.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• InnerOptic: collaborator

Study Sites (1)

Carolinas Health System

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: Carolinas Healthcare System

john.martinie@carolinashealthcare.org

704-446-2772

Study Officials

• David A Iannitti, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: August 16, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 22, 2022
• Results First Posted: August 27, 2018

Record last verified: 2018-07

Locations

US (1)