Cancer of the LiverNCT03753789

Ablation Confirmation Study

A study testing Microwave Ablation in people with Cancer of the Liver and Liver Cancer, run by Ethicon, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
What is being tested?: Microwave Ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 6 sitesUnited States
Study dates: 5 Nov 2019to 12 Oct 2022
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure.
Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
Patients greater than or equal to 22 years of age
Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification
Class A or B functional hepatic reserve based on the Child-Pugh score.
Lesion must be visualized by non-contrast enhanced CT scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).

Who cannot join

Active bacterial infection or fungal infection on the day of the ablation.
Patients with implantable pacemakers or other electronic implants.
Platelet count less than 50,000/mm cubed.
Patients with uncorrectable coagulopathy at the time of ablation.
Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
Physical or psychological condition which would impair study participation.

Show all 12Show fewer

ASA (American Society of Anesthesiologists) score of great or equal to 4.
Use of hydrodissection.
Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
INR greater than 1.8.
Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
Patient judged unsuitable for study participation by the performing physician for any other reason.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

MD Anderson Cancer Center
Houston, Texas, 77030
Loma Linda University Medical Center
Loma Linda, California, 92354
UCLA
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53792
Mayo Clinic
Rochester, Minnesota, 55902
Olives View - UCLA Medical Center
Sylmar, California, 91342

Other trials in United States

About this study

Official title: A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion

Read the detailed description

Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin.

All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Conditions: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Being tested: Microwave Ablation
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microwave AblationDevice
NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Study groups in NCT03753789
Study group	Role	What they receive
Microwave Ablation	Experimental	NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist. Receives: Device: Microwave Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Lesions Where Probe Repositioning is Suggested
Measured: Day 0
Percentage of Lesions Where Re-ablation is Suggested
Measured: Day 0

Secondary outcomes (3)

Technical Success
Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin)
Measured: Day 0
Technique Efficacy
Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin) as assessed by imaging at 6 weeks
Measured: 6 weeks
Hospital Resource Utilization
How many days patients remain in the hospital after the ablation procedure
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201912 Oct 2022

First posted27 Nov 2018
Study start5 Nov 2019
Primary completion12 Oct 2022
Study completion12 Oct 2022

Why it stopped: Combined study endpoints with ongoing registry (NOLA/NEU\_2017\_04)

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 Cancer of the LiverStudies 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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03753789
Sponsor's protocol ID: NEU_2017_03
Status last verified: Jan 2024
First submitted: 31 Oct 2018
Last updated: 5 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion
ClinicalTrials.gov ID: NCT03753789
Acronym / sponsor ID: NEU_2017_03
Conditions: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Study type: Interventional
Recruitment status: TerminatedReason stopped: Combined study endpoints with ongoing registry (NOLA/NEU\_2017\_04)
Enrolment: 46 participants (actual)
Lead sponsor: Ethicon, Inc.Industry (pharma, biotech, devices)
Study start: 5 Nov 2019 (actual)
Primary completion: 12 Oct 2022 (actual)
Study completion: 12 Oct 2022 (actual)
First posted: 27 Nov 2018 (actual)
Results: Posted 5 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Microwave Ablation	Experimental	Device: Microwave AblationNEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure.
Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
Patients greater than or equal to 22 years of age
Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification

Key exclusion criteria (12 listed)

Active bacterial infection or fungal infection on the day of the ablation.
Patients with implantable pacemakers or other electronic implants.
Platelet count less than 50,000/mm cubed.
Patients with uncorrectable coagulopathy at the time of ablation.
Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).

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
Microwave AblationNEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.	Device	Microwave Ablation

Primary outcome

Percentage of Lesions Where Probe Repositioning is Suggested
Time frame: Day 0
Percentage of Lesions Where Re-ablation is Suggested
Time frame: Day 0

3 secondary outcomes

Technical Success
Time frame: Day 0
Technique Efficacy
Time frame: 6 weeks
Hospital Resource Utilization
Time frame: 6 weeks

Results and safety

Results posted to the registry on 5 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Microwave Ablation With Ablation Confirmation Software	38	36

Primary outcome: Percentage of Lesions Where Probe Repositioning is Suggested

Time frame: Day 0. Count of units. Unit: Lesions

Measure	Microwave Ablation n = 38
Actions taken due to AC software indicating probe placement not satisfactory	16
No actions taken despite AC software indicating probe placement not satisfactory	2
No actions taken due to AC software indicating satisfactory probe placement	29

Primary outcome: Percentage of Lesions Where Re-ablation is Suggested

Time frame: Day 0. Count of units. Unit: Lesions

Measure	Microwave Ablation n = 38
Actions taken due to AC software indicating ablation margin not complete	2
No actions taken despite AC software indicating ablation margin not complete	8
No actions taken due to AC software indicating satisfactory margins	37

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microwave Ablation With Ablation Confirmation Software	4 of 38 (10.5%)	4 of 38 (10.5%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Microwave Ablation in people with Cancer of the Liver and Liver Cancer, run by Ethicon, Inc. at 6 sites 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 5 Jan 2024). 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?

Percentage of Lesions Where Probe Repositioning is Suggested (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03753789.

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 5 Jan 2024.