Study to Evaluate VORTX Rx (Theresa)

NCT03741088 | Completed Results DMC FDA Device

• 1 other identifier: 03.CP.0.3
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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

Conditions

Carcinoma, Hepatocellular; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver Tumors

  Number of Lesions that were Successfully Ablated according to technical success definition established in the protocol.

  1-day post ablation

Secondary Outcomes (17)

• Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related

  2 months

• Local Tumor Progression

  1 week, 1 month and 2 months post-procedure.

• Involution of the Ablation Zone

  24hours, 1 week, 1 month and 2 months, post-procedure.

• Assessment of Liver panel_Part 1

  Screening, 24 hours, 1 week, 1 month and 2 months.

• Assessment of Liver Panel_Part 2

  24 hours, 1 week and 1 month and 2 months

Study Arms (1)

VORTX Rx treatment

EXPERIMENTAL

Focused ultrasound ablation of liver tumors.

Device: VORTX Rx treatment

Interventions

VORTX Rx treatment DEVICE

Cavitation-based cellular destruction using focused ultrasound

VORTX Rx treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HistoSonics, Inc.: lead

Study Sites (3)

Clinica Diagonal

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital universitario Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Vall d´Hebrón

Barcelona, 08035, Spain

Location

Related Publications (1)

• 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.

  PMID: 36002243 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: HistoSonics, Inc.

christine.sullivan@histosonics.com

651.398.7586

Study Officials

• Joan Vidal Jove, MD

  Mutua Terrassa , Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: November 14, 2018
• Study Start: March 21, 2018
• Primary Completion: May 15, 2019
• Study Completion: July 17, 2019
• Last Updated: April 20, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-03

Locations

ES (3)