Study to Evaluate VORTX Rx (Theresa) (Theresa)
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|ClinicalTrials.gov Identifier: NCT03741088|
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular Liver Metastases||Device: VORTX Rx treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|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)|
|Actual Study Start Date :||March 21, 2018|
|Actual Primary Completion Date :||May 15, 2019|
|Actual Study Completion Date :||July 17, 2019|
Experimental: VORTX Rx treatment
Focused ultrasound ablation of liver tumors.
Device: VORTX Rx treatment
Cavitation-based cellular destruction using focused ultrasound
- Acute technical performance of the VORTX Rx® medical device for the ablation of primary and metastatic liver tumors [ Time Frame: 1-day post ablation ]targeted tissue ablation will be evaluated using MRI analysis to assess acute technical success defined as the ability of the device to create an ablation zone per planned ablation volume (PAV)
- Safety profile of the VORTX Rx. Incidence of Adverse events (serious and non-serious) that are probably or definitely device-related [ Time Frame: 2 months ]measured on all adverse events (serious and non-serious) that are device-related
- Local tumor progression [ Time Frame: 1 week, 1 month and 2 months post-procedure. ]The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging
- Involution of the ablation zone [ Time Frame: 1 week, 1 month and 2 months, post-procedure. ]The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 1 week, 1 month and 2 months
- Assessment of liver panel. [ Time Frame: 1-day post ablation, 1 week and 1 and 2 months post procedure. ]Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, albumin and bilirubin, gamma glutamyl transpeptidase (GGT), prothrombin time (PT) and international normalized ratio (INR) from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
- Immunologic assessment. [ Time Frame: 1-day post ablation, 1 week and 1 and 2 months post procedure. ]Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: CD3+, CD4+, CD8+, CD45+, CD16+, CD56+ and CD19+, C-reactive protein [CRP], complement C3, C4 and CH50, immunoglobulins [IgG, IgM, IgA], interleukin-6 [IL-6], carcinoembryonic antigen [CEA], alfa-fetoprotein [AFP], Cancer Antigens CA15-3 [Breast Cancer] and CA 19-9 [Pancreatic Cancer]) from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
- Assesment of quality of life by using patient questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) [ Time Frame: 1 and 2 months post procedure. ]
The EORTC QLQ-C30 is a 30-item generic health-related QoL instrument designed to assess cancer patients' physical, psychological and social functioning. It is composed of 9 multi-item scales (5 functional scales [physical, role, cognitive, emotional, and social], a global QoL scale [GQoL], and 3 symptom scales [fatigue, pain, and nausea and vomiting]), 5 single-item symptom scales assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea), and an item on the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. However, a high score for a symptom scale/item represents a high level of symptomatology/problems.
- Pain assessment by VAS scale and analgesic requirements after the ablation procedure. [ Time Frame: 1-day post ablation and 1 week post procedure. ]
Perform pain assessment by a 100 mm visual analog scale (VAS) where 0 is "no pain" and 100 is "the maximum pain possible" at 1-day and 1-week post-procedure.
Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741088
|Esplugues De Llobregat, Barcelona, Spain, 08950|
|Hospital universitario Mutua Terrassa|
|Terrassa, Barcelona, Spain, 08221|
|Hospital Universitario Vall d´Hebrón|
|Barcelona, Spain, 08035|
|Principal Investigator:||Joan Vidal Jove, MD||Mutua Terrassa , Barcelona, Spain|