Study to Evaluate VORTX Rx (Theresa)

NCT ID: NCT03741088

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2019-07-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

VORTX Rx treatment

Focused ultrasound ablation of liver tumors.

Group Type: EXPERIMENTAL

VORTX Rx treatment

Intervention Type: DEVICE

Cavitation-based cellular destruction using focused ultrasound

Interventions

VORTX Rx treatment

Cavitation-based cellular destruction using focused ultrasound

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Written informed consent before any study procedure is performed.
• Subjects of both sexes aged 18 years or older.
• Patients diagnosed with liver cancer, including HCC or liver metastases from breast, pancreas and/or colorectal cancers. If biopsy is required, there will be a minimum of 2-week period after biopsy and before the ablation.
• HCC patients must meet the United Network for Organ Sharing and Organ Procurement and Transplantation Network (UNOS-OPTN) class 5 criteria for HCC (52).
• Liver metastases patients must meet minimum criteria of liver biopsy and/or tissue diagnosis of primary tumor or metastatic tumor with new or growing liver tumors radiologically consistent with metastases.
• Patients with liver cancer not candidates for surgical resection and/or not suitable for other locoregional treatments or patients who have not responded to or relapsed from conventional therapies.
• Previous treatment with chemotherapy and/or radiotherapy is permitted provided that these treatments have been discontinued more than 2 weeks before the ablation and whenever patients have recovered from any related toxicity (53).
• Previous treatment with immunotherapies is permitted provided that these therapies have been discontinued at least 4 weeks before the ablation and whenever patients have recovered from any related toxicity.
• Previous ablation/surgery on other tumors different from those that will be targeted with the VORTX Rx® is allowed whenever a minimum of 2 weeks has elapsed since the prior procedure(s).
• Tumor to be targeted for ablation will be clearly separated from other tumors or other critical areas (i.e. located in different segments of the liver) and located in segment 2, 3, 4, 5 or 6.
• Largest diameter of targeted tumor ≤3 cm.
• Tumor that will be targeted at a depth <10 cm from the skin surface.
• Must have an adequate acoustic window in the abdominal space to be able to visualize targeted tumor using ultrasound imaging; also must be able to visualize targeted tumor using MRI with optional CT imaging at investigator discretion.
• Patients who can undergo general anesthesia.
• Liver function score of Child-Pugh A or Child-Pugh B.
• ECOG PS 0, 1 or 2 at screening.
• Adequate liver function (ALT and AST < 2.5 x upper limit of normal [ULN]), renal function (serum creatinine <2 ULN and/or bilirubin <2.5 UNL) and hematologic function (neutrophil count > 1.0 x 109/L and platelet > 50 x 109/L).
• An INR <2 within the last 7 days prior to the ablation in patients receiving anticoagulants, and an INR <1.5 for patients not treated with anticoagulants.
• Platelets level >50 x 109/L within the last 7 days prior to the ablation.

Exclusion Criteria

• Patients who decline or are unable to understand, provide or are unwilling to sign an informed consent form.
• Pregnant or nursing (lactating) women; women of childbearing potential and sexually active that are unwilling to use adequate contraception (such as oral contraceptives, intrauterine contraceptive device or barrier method with spermicide or surgical sterilization).
• Targeted tumor not clearly separated (i.e. located in the same liver segment as another tumor).
• Targeted tumor located in liver segments 1, 7 or 8.
• Targeted tumor >3 cm.
• Tumor that will be targeted >10 cm from the skin surface.
• Tumor not clearly visible with diagnostic ultrasound and MRI.
• Liver function score of Child-Pugh C.
• Liver volume reserve <40% as measured by CT Scan (54).
• Major surgical procedure, biopsy or significant traumatic injury <2 weeks prior to the procedure or has not recovered from side effects/complications of such procedure or trauma.
• Patient who has not recovered to grade 1 or better from any AEs (except alopecia, fatigue, nausea, vomiting) related to previous anti neoplastic therapies.
• BMI >30.
• Parkinson's disease.
• History of bleeding disorders (e.g. von Willebrand disease) or patients suspected to have a bleeding disorder.
• Not able to temporarily discontinue warfarin, clopidogrel or any other long-acting anticoagulants at least two weeks before the procedure.
• Initiation of any anticancer treatment during the screening period and during the follow-up study visits.
• Life expectancy to be less than 6 months.
• Unable or unwilling to complete all required screening and/or follow-up assessments.
• Patients under ongoing treatment with an investigational medication or medical device that conflicts with the study device.
• Patients for whom the investigator considers that the ablation is not in the patient's best interest.
• Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
• Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
• Patients with known sensitivity to iodine.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HistoSonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Vidal Jove, MD

Role: PRINCIPAL_INVESTIGATOR

Mutua Terrassa , Barcelona, Spain

Locations

Clinica Diagonal

Esplugues de Llobregat, Barcelona, Spain

Hospital universitario Mutua Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario Vall d´Hebrón

Barcelona, , Spain

Countries

Spain

References

Vidal-Jove J, Serres X, Vlaisavljevich E, Cannata J, Duryea A, Miller R, Merino X, Velat M, Kam Y, Bolduan R, Amaral J, Hall T, Xu Z, Lee FT Jr, Ziemlewicz TJ. First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study. Int J Hyperthermia. 2022;39(1):1115-1123. doi: 10.1080/02656736.2022.2112309.

Reference Type: DERIVED

PMID: 36002243 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

03.CP.0.3

Identifier Type: -

Identifier Source: org_study_id