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Study to Evaluate VORTX Rx (Theresa) — Theresa  

Carcinoma, Hepatocellular Clinical Trial

Official title:
Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors (Theresa Study)

Clinical Trial Summary

Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors

Clinical Trial Description

The study will assess the technical performance of the VORTX Rx device to deliver acoustic energy for cavitation-based cellular destruction. The planned duration of a single target tumor will be 60 minutes or less in a single session and adjusted intra-procedurally as necessary per investigator discretion. Subjects in this study must have an adequate acoustic window in the abdominal space in order to be eligible for enrollment. All patients who undergo ablation with the investigation device will be treated in a hospital environment under general anesthesia not to exceed four hours. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03741088
Study type Interventional
Source HistoSonics, Inc.
Contact
Status Completed
Phase N/A
Start date March 21, 2018
Completion date July 17, 2019
View Details
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