A Study to Evaluate Ablation in Patients with A Soft-Tissue Liver Lesion
Tab Title Description
Describes 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.
- Rochester, Minnesota: 19-006521
NCT ID: NCT03753789
Sponsor Protocol Number: NEU_2017_03
About this study
The purpose of this study is to evaluate the use of the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
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.
- A patient with at least one soft-tissue liver lesion ≤ 5 cm undergoing MWA using the NEUWAVE Microwave Ablation System. Note: A patient cannot have more than three 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 ≥ 22 years old.
- Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG]).
- 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).
- Active bacterial infection or fungal infection on the day of the ablation.
- Patients with implantable pacemakers or other electronic implants.
- Platelet count < 50,000/mm^3
- Patients with uncorrectable coagulopathy at the time of ablation.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Use of hydrodissection.
- Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, within 30 days prior to the study ablation procedure.
- Systemic Chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
- INR > 1.85.
- 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.
Eligibility last updated 9/7/21. 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
Mayo Clinic principal investigator
Grant Schmit, M.D.
Closed for enrollment
Publications are currently not available