Completed

Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study

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What is being tested

Advanced Image Guidance

Device
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: April 22, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorWake Forest University Health Sciences
Last updated: April 22, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsLiver DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialCarcinoma, HepatocellularLiver Neoplasms

Criteria

2 inclusion criteria required to participate
Individuals who are candidates for microwave ablation surgery

Individuals who have hepatocellular carcinoma

2 exclusion criteria prevent from participating
Individuals who are not a candidate for laparoscopic microwave ablation surgery

Individuals who do not have hepatocellular carcinoma

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Carolinas Health System

Charlotte, United StatesOpen Carolinas Health System in Google Maps
CompletedOne Study Center