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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VORTX Rx treatment | Experimental | Focused ultrasound ablation of liver tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VORTX Rx treatment | Device | Cavitation-based cellular destruction using focused ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related | Number of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related | 2 months |
| Local Tumor Progression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Vidal Jove, MD | Mutua Terrassa , Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Diagonal | Esplugues de Llobregat | Barcelona | 08950 | Spain | ||
| Hospital universitario Mutua Terrassa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36002243 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VORTX Rx Treatment | Focused ultrasound ablation of liver tumors. VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VORTX Rx Treatment | Focused ultrasound ablation of liver tumors. VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Units | lesions | 1-day post ablation | lesions | lesions |
|
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VORTX Rx Treatment | Focused ultrasound ablation of liver tumors. VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEVER | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaminase elevation | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | HistoSonics, Inc. | 651.398.7586 | christine.sullivan@histosonics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2018 | Nov 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2020 | Nov 17, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2018 | Nov 17, 2020 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Number of patients who have indicated local tumor progression in at least one visit (1 week, 1 month, 2 months) for each tumor ablated. The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging |
| 1 week, 1 month and 2 months post-procedure. |
| Involution of the Ablation Zone | The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 24h, 1 week, 1 month and 2 months | 24hours, 1 week, 1 month and 2 months, post-procedure. |
| Assessment of Liver panel_Part 1 | Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma glutamyl transpeptidase (GGT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. | Screening, 24 hours, 1 week, 1 month and 2 months. |
| Assessment of Liver Panel_Part 2 | Liver panel will be evaluated on the basis of the change of albumin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. | 24 hours, 1 week and 1 month and 2 months |
| Assessment of Liver Panel_Part 3 | Liver panel will be evaluated on the basis of the change of bilirubin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure | 24 hours, 1 week and 1month and 2 months |
| Assessment of Liver Panel_part 4 | Liver panel will be evaluated on the basis of the change of prothrombin time (PT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure | 24 hours, 1 week and 1month and 2 months |
| Assessment of Liver Panel_Part 5 | Liver panel will be evaluated on the basis of the change of International normalized ratio (INR = A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. Normal values for INR: 0.9-1.3. | 24 hours, 1 week and 1 month and 2 months |
| Immunologic Assessment_Part 1 | 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+ from Baseline/Screening to 1-day post ablation, 1 week and 1 and 2 months post procedureprocedure. | Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedure |
| Immunologic Assessment_Part 2 | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments: C-reactive protein [CRP], from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Screening, 24 hours, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 3 | 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): complement C3 and C4, immunoglobulins [IgG, IgM, IgA] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 4 | 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: complement CH50, 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. | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 5 | 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): interleukin-6 [IL-6] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 6 | 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): carcinoembryonic antigen [CEA] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Screening, 24 hours post ablation, 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) | 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. | Screening, 1 and 2 months post procedure. |
| Pain Assessment by VAS Scale | 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. | 1-day post ablation and 1 week post procedure. |
| Analgesic Requirements After the Ablation Procedure | Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure. | in the 24-hour period post-procedure and during the one week period post-procedure |
| Terrassa |
| Barcelona |
| 08221 |
| Spain |
| Hospital Universitario Vall d´Hebrón | Barcelona | 08035 | Spain |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of live tumors | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | 0 - Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
|
| lesions |
|
|
| Secondary | Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related | Number of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related | Although only 5 participants performed all protocol visits, adverse events from all patients were reported and analyzed. Any of the 55 AEs reported was device-related. | Posted | Number | Adverse Events | 2 months | Adverse Events | Adverse Events |
|
|
|
| Secondary | Local Tumor Progression | Number of patients who have indicated local tumor progression in at least one visit (1 week, 1 month, 2 months) for each tumor ablated. The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging | Posted | Count of Participants | Participants | 1 week, 1 month and 2 months post-procedure. |
|
|
|
| Secondary | Involution of the Ablation Zone | The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 24h, 1 week, 1 month and 2 months | Posted | Mean | Standard Deviation | cubic centimeters | 24hours, 1 week, 1 month and 2 months, post-procedure. | lesions | lesions |
|
|
|
| Secondary | Assessment of Liver panel_Part 1 | Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma glutamyl transpeptidase (GGT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. | Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation) | Posted | Mean | Standard Deviation | U/L | Screening, 24 hours, 1 week, 1 month and 2 months. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Assessment of Liver Panel_Part 2 | Liver panel will be evaluated on the basis of the change of albumin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. | Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation) | Posted | Mean | Standard Deviation | g/L | 24 hours, 1 week and 1 month and 2 months | ablation procedures | ablation procedures |
|
|
|
| Secondary | Assessment of Liver Panel_Part 3 | Liver panel will be evaluated on the basis of the change of bilirubin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure | Posted | Mean | Standard Deviation | mg/dL | 24 hours, 1 week and 1month and 2 months | ablation procedures | ablation procedures |
|
|
|
| Secondary | Assessment of Liver Panel_part 4 | Liver panel will be evaluated on the basis of the change of prothrombin time (PT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure | Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation) | Posted | Mean | Standard Deviation | percentage of activity | 24 hours, 1 week and 1month and 2 months | ablation procedures | ablation procedures |
|
|
|
| Secondary | Assessment of Liver Panel_Part 5 | Liver panel will be evaluated on the basis of the change of International normalized ratio (INR = A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. Normal values for INR: 0.9-1.3. | Posted | Mean | Standard Deviation | ratio | 24 hours, 1 week and 1 month and 2 months | ablation procedures | ablation procedures |
|
|
|
| Secondary | Immunologic Assessment_Part 1 | 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+ from Baseline/Screening to 1-day post ablation, 1 week and 1 and 2 months post procedureprocedure. | Posted | Mean | Standard Deviation | cells/uL | Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedure | ablation procedures | ablation procedures |
|
|
|
| Secondary | Immunologic Assessment_Part 2 | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments: C-reactive protein [CRP], from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Posted | Mean | Standard Deviation | mg/L | Screening, 24 hours, 1 week and 1 and 2 months post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Immunologic Assessment_Part 3 | 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): complement C3 and C4, immunoglobulins [IgG, IgM, IgA] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Posted | Mean | Standard Deviation | mg/dL | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Immunologic Assessment_Part 4 | 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: complement CH50, 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. | Posted | Mean | Standard Deviation | U/ml | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Immunologic Assessment_Part 5 | 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): interleukin-6 [IL-6] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Posted | Mean | Standard Deviation | pg/dl | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Immunologic Assessment_Part 6 | 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): carcinoembryonic antigen [CEA] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. | Posted | Mean | Standard Deviation | ng/ml | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | 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. | Posted | Mean | Standard Deviation | score on a scale | Screening, 1 and 2 months post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Pain Assessment by VAS Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-day post ablation and 1 week post procedure. | ablation procedures | ablation procedures |
|
|
|
| Secondary | Analgesic Requirements After the Ablation Procedure | Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure. | Number of patients with at least one drug due to Post-procedure pain (concomitant medication form). | Posted | Count of Participants | Participants | in the 24-hour period post-procedure and during the one week period post-procedure |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| 7 |
| 8 |
| HYPOCALCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| Abdominal discomfort | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Adverse reaction to analeptics and opioid receptor antagonists | Nervous system disorders | Systematic Assessment |
|
| Alkaline phosphatase increase | Hepatobiliary disorders | Systematic Assessment |
|
| ALT increase | Hepatobiliary disorders | Systematic Assessment |
|
| Anemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Appetite increase | Metabolism and nutrition disorders | Systematic Assessment |
|
| Ascites | Hepatobiliary disorders | Systematic Assessment |
|
| AST increase | Hepatobiliary disorders | Systematic Assessment |
|
| Chest punctures | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Choluria | Renal and urinary disorders | Systematic Assessment |
|
| Coccyx pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Desquamative lesions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
|
| General pain | General disorders | Systematic Assessment |
|
| GGT increase | Hepatobiliary disorders | Systematic Assessment |
|
| Itchy skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
|
| Left leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lipotomy | Nervous system disorders | Systematic Assessment |
|
| Malleolar edema with fovea | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Occasional fever | General disorders | Systematic Assessment |
|
| Pain in right shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in right side | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right basal pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sciatic pain | Nervous system disorders | Systematic Assessment |
|
| Swollen ankles | Vascular disorders | Systematic Assessment |
|
| Tingling in feet and hands | Nervous system disorders | Systematic Assessment |
|
The results or conclusions of this study will be reported at scientific congresses and published in scientific journals. The investigator agrees to maintain this information in strict confidence, and will not use it for any other purpose without the written authorization of the sponsor.
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
|
| Ablation zone volume (cm3): 2 months |
|
| Title | Measurements |
|---|---|
|
| AST 1 month |
|
| AST 2 months |
|
| ALT Screening |
|
| ALT 24 hours |
|
| ALT 1 week |
|
| ALT 1 month |
|
| ALT 2 months |
|
| GGT Screening |
|
| GGT 24 hours |
|
| GGT 1 week |
|
| GGT 1 month |
|
| GGT 2 months |
|
| Alkaline Phosphatase Screening |
|
| Alkaline Phosphatase 24 hours |
|
| Alkaline Phosphatase 1 week |
|
| Alkaline Phosphatase 1 month |
|
| Alkaline Phosphatase 2 months |
|
| Title | Measurements |
|---|---|
|
| Albumin 1 month |
|
| Albumin 2 months |
|
| Title | Measurements |
|---|---|
|
| Total Bilirrubin 1 month |
|
| Total Bilirrubin 2 months |
|
| Title | Measurements |
|---|---|
|
| Prothrombin time 1 month |
|
| Prothrombin time 2 months |
|
| Title | Measurements |
|---|---|
|
| INR 1 month |
|
| INR 2 months |
|
| Title | Measurements |
|---|---|
|
| CD3+ (T cells) 1 month |
|
| CD3+ (T cells) 2 months |
|
| CD4+ (T helper cells) Screening |
|
| CD4+ (T helper cells) 24 hours |
|
| CD4+ (T helper cells) 1 week |
|
| CD4+ (T helper cells) 1 month |
|
| CD4+ (T helper cells) 2 months |
|
| CD8+ (T suppressor/cytotoxic cells) Screening |
|
| CD8+ (T suppressor/cytotoxic cells) 24 hours |
|
| CD8+ (T suppressor/cytotoxic cells) 1 week |
|
| CD8+ (T suppressor/cytotoxic cells) 1 month |
|
| CD8+ (T suppressor/cytotoxic cells) 2 months |
|
| CD45+ (leucocyte common antigen) Screening |
|
| CD45+ (leucocyte common antigen) 24 hours |
|
| CD45+ (leucocyte common antigen) 1 week |
|
| CD45+ (leucocyte common antigen) 1 month |
|
| CD45+ (leucocyte common antigen) 2 months |
|
| CD16+ Screening |
|
| CD16+ 24 hours |
|
| CD16+ 1 week |
|
| CD16+ 1 month |
|
| CD16+ 2 months |
|
| CD56+ (NKT cells) Screening |
|
| CD56+ (NKT cells) 24 hours |
|
| CD56+ (NKT cells) 1 week |
|
| CD56+ (NKT cells) 1 month |
|
| CD56+ (NKT cells) 2 months |
|
| CD19+ (B-lymphocyte antigen) Screening |
|
| CD19+ (B-lymphocyte antigen) 24 hours |
|
| CD19+ (B-lymphocyte antigen) 1 week |
|
| CD19+ (B-lymphocyte antigen) 1 month |
|
| CD19+ (B-lymphocyte antigen) 2 months |
|
|
| C reactive protein 1 month |
|
| C reactive protein 2 months |
|
| Title | Measurements |
|---|---|
|
| Complement C3 1 month |
|
| Complement C3 2 months |
|
| Complement C4 Screening |
|
| Complement C4 24 hours |
|
| Complement C4 1 week |
|
| Complement C4 1 month |
|
| Complement C4 2 months |
|
| IgG Screening |
|
| IgG 24 hours |
|
| IgG 1 week |
|
| IgG 1 month |
|
| IgG 2 months |
|
| IgM Screening |
|
| IgM 24 hours |
|
| IgM 1 week |
|
| IgM 1 month |
|
| IgM 2 months |
|
| IgA Screening |
|
| IgA 24 hours |
|
| IgA 1 week |
|
| IgA 1 month |
|
| IgA 2 months |
|
| Title | Measurements |
|---|---|
|
| Complement CH50 1 month |
|
| Complement CH50 2 months |
|
| AFP Screening |
|
| AFP 24 hours |
|
| AFP 1 week |
|
| AFP 1 month |
|
| AFP 2 months |
|
| CA 15-3 (breast cancer) Screening |
|
| CA 15-3 (breast cancer) 24 hours |
|
| CA 15-3 (breast cancer) 1 week |
|
| CA 15-3 (breast cancer) 1 month |
|
| CA 15-3 (breast cancer) 2months |
|
| CA 19-9 (pancreatic cancer) Screening |
|
| CA 19-9 (pancreatic cancer) 24 hours |
|
| CA 19-9 (pancreatic cancer) 1 week |
|
| CA 19-9 (pancreatic cancer) 1 month |
|
| CA 19-9 (pancreatic cancer) 2 months |
|
| Title | Measurements |
|---|---|
|
| Interleukin-6 1 month |
|
| Interleukin-6 2 months |
|
| Title | Measurements |
|---|---|
|
| CEA 1 month |
|
| CEA 2 months |
|
|
| Physical functioning Screening |
|
| Physical functioning 1 month |
|
| Physical functioning 2 months |
|
| Role functioning screening |
|
| Role functioning 1 month |
|
| Role functioning 2 months |
|
| Emotional functioning Screening |
|
| Emotional functioning 1 month |
|
| Emotional functioning 2 months |
|
| Cognitive functioning Screening |
|
| Cognitive functioning 1 month |
|
| Cognitive functioning 2 months |
|
| Social functioning Screening |
|
| Social functioning 1 month |
|
| Social functioning 2 months |
|
| Fatigue Screening |
|
| Fatigue 1 month |
|
| Fatigue 2 months |
|
| Nausea and vomiting Screening |
|
| Nausea and vomiting 1 month |
|
| Nausea and vomiting 1 months |
|
| Pain Screening |
|
| Pain 1 month |
|
| Pain 2 months |
|
| Dyspnea Screening |
|
| Dyspnea 1 month |
|
| Dyspnea 2 months |
|
| Insomnia Screening |
|
| Insomnia 1 month |
|
| Insomnia 2 months |
|
| Appetite loss Screening |
|
| Appetite loss 1 month |
|
| Appetite loss 2 months |
|
| Constipation Screening |
|
| Constipation 1 month |
|
| Constipation 2 months |
|
| Diarrhea Screening |
|
| Diarrhea 1 month |
|
| Diarrhea 2 months |
|
| Financial difficulties Screening |
|
| Financial difficulties 1 month |
|
| Financial difficulties 2 months |
|