Carcinoma, HepatocellularNCT01666145
Advanced Image Guidance Utilized in Liver Surgery
A study testing Advanced Image Guidance in people with Carcinoma, Hepatocellular, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Advanced Image Guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who have hepatocellular carcinoma.
- Individuals who are candidates for microwave ablation surgery.
Who cannot join
- Individuals who do not have hepatocellular carcinoma.
- Individuals who are not a candidate for laparoscopic microwave ablation surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Health System
Charlotte, North Carolina, 28204
About this study
Official title: Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
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.
Read the 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Advanced Image Guidance
- Keywords
- Hepatocellular Cancer, Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Adult
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Image GuidanceDevice
Also called AIM
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Imaging | Experimental | Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement. Receives: Device: Advanced Image Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- InnerOptic
- Responsible party
- Sponsor
- Investigators
- David A Iannitti, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666145
- Sponsor's protocol ID
- 12-11-13B
- Status last verified
- Jul 2018
- First submitted
- 7 May 2012
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT01666145
- Acronym / sponsor ID
- 12-11-13B
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular Cancer, Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- InnerOptic
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 27 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Imaging | Experimental | Device: Advanced Image GuidanceLaparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who have hepatocellular carcinoma.
- Individuals who are candidates for microwave ablation surgery.
Key exclusion criteria (2 listed)
- Individuals who do not have hepatocellular carcinoma.
- Individuals who are not a candidate for laparoscopic microwave ablation surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Image GuidanceAlso: AIMPatients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement. | Device | Intraoperative Imaging |
Primary outcome
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.
1 secondary outcome
Percentage of Participants With Significant 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Iannitti, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Image Guidance in people with Carcinoma, Hepatocellular, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.