NEUWAVE MW LIVER ABLATION--POST MARKETING SOFTWARE EVALUATION

Summary

PRIMARY OBJECTIVE The primary objective of this study is to examine whether the feedback from the AC software impacts the performing physician s (i.e. the individual performing the ablatio procedure) decision making in terms of probe(s) position, ablation time, or number of ablations based on insufficient ablation margins.


Inclusion Criteria

  • 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
Show more

Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Liver

Principal Investigator

Wachsman, Ashley

Co-Investigators

Alexandra Gangi, Allan Silberman, H. Gabriel Lipshutz, Jonathan Steinberger, Nicholas Nissen, Tsuyoshi Todo

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000188

ClinicalTrials.gov ID

NCT03753789

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Liver

Principal Investigator

Wachsman, Ashley

Age Group

Adult

Phase

N/A

IRB Number

NEU-2017-03

ClinicalTrials.gov ID

NCT03753789

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?