NCT03741088

Study to Evaluate VORTX Rx (Theresa)

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Carcinoma, Hepatocellular
• Liver Metastases

Interventions

Type	Name	Description
DEVICE	VORTX Rx treatment	Cavitation-based cellular destruction using focused ultrasound

Timeline

• Start date: 2018-03-21
• Primary completion: 2019-05-15
• Completion: 2019-07-17
• First posted: 2018-11-14
• Last updated: 2021-04-20
• Results posted: 2021-02-25

Locations

3 sites across 1 country: Spain

Regulatory

• FDA-regulated device study