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| Name | Class |
|---|---|
| Tau-MEDICAL Co., Ltd. | INDUSTRY |
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This study aims to evaluate the safety of the CAROL device for treating lung tumors in patients diagnosed with non-small cell lung cancer (NSCLC) with tumor size ≤ 2 cm (cT1b). The primary objective is to assess safety by monitoring and grading adverse events using the CTCAE v5.0 criteria at one month following the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAROL Device Treatment for Early-Stage NSCLC | Experimental | Participants in this single-arm study will undergo treatment with the CAROL device for localized lung tumors (NSCLC ≤ 2 cm, cT1b). All participants will receive a single CAROL procedure using a conformable electrode, followed by surgical resection of the tumor. The first 3 sentinel participants will receive a maximum dose of 0.3 mL of the conformable electrode. The next 4 participants will receive up to 2.0 mL. Safety and preliminary efficacy will be assessed through scheduled follow-up visits, including imaging, pulmonary function testing, laboratory assessments and pain monitoring. Adverse events will be monitored throughout the study, with grading based on CTCAE v5.0, specifically focusing on "Respiratory, thoracic, and mediastinal disorders." The study includes visits at screening, pre-procedure, post-procedure (24-36 hours), pre- and post-resection, and follow-up at approximately one and three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAROL NSCLC treatment Device | Device | Participants in this single-arm study will undergo treatment with the CAROL device for localized lung tumors (NSCLC ≤ 2 cm, cT1b). All participants will receive a single CAROL procedure using a conformable electrode, followed by surgical resection of the tumor. The first 3 sentinel participants will receive a maximum dose of 0.3 mL of the conformable electrode. The next 4 participants will receive up to 2.0 mL. Safety and preliminary efficacy will be assessed through scheduled follow-up visits, including imaging, pulmonary function testing, laboratory assessments and pain monitoring. Adverse events will be monitored throughout the study, with grading based on CTCAE v5.0, specifically focusing on "Respiratory, thoracic, and mediastinal disorders." The study includes visits at screening, pre-procedure, post-procedure (24-36 hours), pre- and post-resection, and follow-up at approximately one and three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Common Terminology Criteria for Adverse Events(CTCAE) | Graded using CTCAE grade (v5.0) criteria(CTCAE) The CTCAE utilizes a scale ranging from Grade 1 (mild) to Grade 5 (death-related) to classify the severity of adverse events. A higher CTCAE grade indicates increased severity of the adverse event, signifying a worse outcome. | 1 month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Success rate of CAROL device positioning at the target site The success rate of CAROL device positioning at the target site immediately after application, as assessed by fluoroscopic imaging and /or bronchoscopic visualization during the procedure. Proper positioning is defined as complete coverage of the target segmental bronchus by the ablation electrode without malposition or dislodgement. Frequencies and percentages will be presented to summarise the success rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Quality of Life scores | Evaluation of Quality of Life scores(EQ-5D) The EQ-5D questionnaire will be used to assess patient's health-related quality of life. The EQ-5D includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on 5 levels. Scores will be converted to an index value ranging from -0.594 (worst health state) to 1.000 (perfect health), based on country-specific value sets. Higher scores indicate better health-related quality of life. |
Inclusion Criteria:
Those who meet all the following criteria are eligible to participate in the clinical trial.
Adults 18 years of age or older at the time of screening
NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection
Suitable candidate for resection per standard of practice (Lobectomy)
NSCLC is confirmed pathologically for the tissue that will be ablated
Location of tumour:
Signed free and informed consent as prescribed by hospital policies.
Exclusion Criteria:
Those who meet any of the following criteria are excluded from this clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Steinfort, MD, PhD | Contact | +62 407 331 446 | Daniel.Steinfort@mh.org.au | |
| Jaeyoung Seo | Contact | +82 10 4844 3203 | sjy@tau-medical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Melbourne Hospital | Recruiting | Melbourne | Victoria | 3050 | Australia |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Multi-center, open label, single arm, early feasibility study
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| Immediately after application (measured by imaging during the procedure) |
| Procedural success | Successful delivery of the ablation treatment for lung cancer using the CAROL system, performed according to the Instruction for Use (IFU) and treatment plan. Success will be determined based on the following criteria: Successful delivery of the CAROL catheter to the target site Successful injection of the Conformable Electrode (E-GaIn) Achievement of target ablation temperature Retrieval of the device without malfunction | Immediately after procedure (intraoperative and early postoperative period) |
| Procedural success | Pathological analysis Pathological evidence of effective ablation will be evaluated using hematoxylin and eosin (H&E) staining to assess tissue viability. The extent of the coagulative necrotic zone relative to the tumor location will be quantified by pathologists. Descriptive statistics (mean, range) will summarize the extent of ablation effectiveness. | 5 ~ 10 days after lung resection |
| Procedural success | Imaging data evaluation Imaging data from computed tomography (CT) scans will be assessed to evaluate the extent of ablation, including lesion size and ablation margin relative to baseline. Measurements will be reviewed by radiologists using standard radiologic assessment criteria. Descriptive statistics will be presented for changes in treated areas. | 2~9 days after the CAROL procedure |
| 2~9 days after CAROL the procedure |
| Evaluation of pain scores | Visual Analogue Scale (VAS) Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated instrument consisting of a 10 cm horizontal line anchored by "no pain" (0) and "worst imaginable pain" (10). Participants will be asked to indicate their current level of pain on the scale. Higher scores indicate greater pain severity. | 2~9 days after the CAROL procedure |
| Predicted and actual volume of liquid metal delivered | The volume of Conformable Electrode (E-GaIn) predicted during the planning phase will be compared with the actual volume delivered during the CAROL procedure. Measurements will be obtained from procedure records and delivery system readouts. Differences will be quantified in milliliters (mL) and summarized using descriptive statistics. | 6~14 days after the CAROL procedure |
| Predicted and actual ablation size | The ablation size predicted during pre-treatment planning will be compared to the actual ablation zone measured by post-procedural imaging. Ablation volume will be quantified in cubic centimeters (cm3) using CT or MRI data, and descriptive statistics will be used to summarize differences. | 6 to 14 days after the CAROL procedure |
| Distribution pattern of conformable electrode in varying bronchial anatomies | CT images will be used to assess the spatial distribution of the Conformable Electrode (E-GaIn) across different bronchial structures. Anatomical coverage (e.g., lobar/segmental bronchi), symmetry, and dispersion pattern will be visually classified and quantitatively measured by independent radiologists. Descriptive statistics will summarize the observed distribution patterns. | Day 23 to Day 37 after the CAROL procedure |
| Feasibility of procedural planning in various bronchial geometries | The feasibility of procedural planning will be assessed based on whether the planned delivery paths through bronchial geometries were technically achievable during procedure simulation using CT-based airway mapping. | Day 23 to Day 37 after the CAROL procedure |
| Accuracy of procedural planning in various bronchial geometries | Accuracy will be assessed by comparing the planned device path (based on CT-based bronchial mapping) with the actual path and final position as observed in post-procedure CT imaging. The deviation between the planned and actual paths will be measured in millimeters in three-dimensional space by independent radiologists. Descriptive statistics (mean, standard deviation, and range) will be used to summarize the accuracy for each bronchial geometry type (e.g., lobar, segmental). | Day 23 to Day 37 after the CAROL procedure |
| User feedback score on device usability and operating handling characteristics | User feedback will be collected using a standardized questionnaire assessing device usability and operating handling characteristics, including perceived ease of use, catheter maneuverability, and procedural confidence. Responses will be summarized using descriptive analysis of response frequencies and thematic grouping of any free-text comments. | Day 23 to Day 37 after the CAROL procedure |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |