NOLA (NeuWave Observational Liver Ablation) Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 20-001795
NCT ID: NCT04107766
Sponsor Protocol Number: NEU_2017_04
About this study
The purpose of this study is to create a registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the NEUWAVE Microwave Ablation System per the device's Instructions for Use (IFU).
- Patients with signed informed consent (or waiver approved by IRB/EC) who are willing to comply with the assessment schedule, and willing to have data included in the database.
- Patients ≥ 22 years old at the time of informed consent (or waiver approved by IRB/EC).
Exclusion Criteria:
- Patients < 22 years of age.
- Patients with a life expectancy of less than 1 year, in the opinion of the treating physician.
- Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation.
- Patient is currently participating, or planning to participate, in another NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the liver.
- Note: roll-over patients from previous NeuWave trials are permitted.
Eligibility last updated 12/20/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Beau Toskich, M.D. |
Closed for enrollment |
Contact information:
Clinical Studies Unit
(904) 953-2255
|
More information
Publications
Publications are currently not available