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The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use.
This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.
The primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in subjects undergoing lung ablation procedures.
The primary endpoint is the composite rate of adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
The following secondary endpoints will be evaluated:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopic ablation catheter | Device | The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically and will be used to conduct bronchoscopic ablations in the lung using the superDimension™ navigation system. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects included must have a cancerous lung nodule, and will be candidates for an elective ENB and lung ablation procedure. Subjects themselves will need to provide written consent and agree to attend study visits and complete questionnaires. Up to 30 subjects will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Kelvin Lau, MA DPhil FRCS(CTh) | St Bartholomew's Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong | ||||
| St. Bartholomew's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAVABLATE (Single-arm Study) | Observational NAVABLATE arm (single-arm, no comparator) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
30 subjects were enrolled. The bronchoscopic ablation procedure was performed on 1 lesion for each subject.
| ID | Title | Description |
|---|---|---|
| BG000 | NAVABLATE (Single-arm Study) | Observational NAVABLATE arm (single-arm study, no comparator) |
| 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 | Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Count of Participants | Participants | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
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Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure.
Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
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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 | NAVABLATE (Single-arm Study) | Observational NAVABLATE arm (single-arm study, no comparator) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Krzykowski | Medtronic | 763-202-3325 | Julie.Krzykowski@Medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 26, 2019 | Dec 20, 2021 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2018 | Dec 20, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| Number of Participants With AEs Related to Study Procedure or Study Devices |
Rate of all AEs related to the procedure or study devices through 1-month follow-up. Rate of all AEs related to the procedure or study devices through 1-month follow-up was also measured based on Common Terminology Criteria for Adverse Events (CTCAE) classification. CTCAE grading is evaluated on a scale from 1-5 (1 - mild; intervention not indicated; 5 - most severe; death related to AE). Subjects could have more than one AE with different CTCAE Grades. |
| During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
| Number of Participants With SAEs Related to the Study Procedure or Study Devices | Rate of all SAEs related to the procedure or study devices through 1-month follow-up. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
| Score of Patient Satisfaction, Pain, and Breathlessness | Patient satisfaction, pain, and breathlessness (Bronchoscopic Ablation Patient Pain and Satisfaction Survey) At the 1-month visit, subjects assessed their pain/discomfort and breathlessness based on how they recall feeling at 3 different timepoints. The timepoints were immediately, one week, and one month after the bronchoscopic ablation procedure. Pain or discomfort were evaluated on a scale from 0-10 (10 - severe/interferes with basic needs). Breathlessness was evaluated on a scale from 1-5 (5 - too breathless to leave the house, or breathless when undressing). Subjects also evaluated their willingness to have the procedure performed again on a scale from 1-5 (5 - extremely likely), how likely they would recommend the procedure to family and friends on a scale from 1-5 (5 - extremely likely), and how satisfied they were with the procedure on a scale from 1-5 (5 - extremely satisfied). | Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure) |
| Score of Current Health State From Quality of Life Survey | Quality of life evaluation based on EuroQol [EQ-5D-3L] survey. The questions from the survey surround current health status. The subjects assessed their current health state on a scale of 0-100 (100 being the best health state imaginable). | Baseline and 1-month |
| Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol | Technical success: An evaluation of whether the lung nodule was treated according to the study protocol as determined at the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could not be executed completely, either for technical reasons or for reasons related to comorbid disease. | Immediately post-procedure |
| Number of Lung Nodules Evaluated as Being Effectively Ablated | Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by CT imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure). | 1-month follow-up (an average of 20-40 days post-procedure) |
| London |
| United Kingdom |
| Lesions |
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| Participants |
| Participants |
|
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| Age, Continuous | Mean | Standard Deviation | Years | Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
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| Chronic obstructive pulmonary disease | Count of Participants | Participants | Participants |
|
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| Tobacco use (current or former) | Count of Participants | Participants | Participants |
|
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| Prior lung procedures performed | Subjects could have more than one prior lung procedure performed. | Count of Participants | Participants | Participants |
|
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| No prior lung procedure performed | Count of Participants | Participants | Participants |
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| Eligibility for Lung surgery or SBRT | Count of Participants | Participants | Participants |
|
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| State of cancer diagnosis | Count of Participants | Participants | Participants |
|
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| Nodule size (mm) | Nodule size from pre-procedure CT scan | Mean | Standard Deviation | millimeters | Lesions |
|
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| Lobe zone of nodule | Count of Units | Lesions | Lesions |
|
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| Lobe location | Count of Participants | Participants | Participants |
|
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| Bronchus sign present | Bronchus sign present based on pre-procedure CT scan | Count of Participants | Participants | Participants |
|
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| Lesion morphology | Count of Units | Lesions | Lesions |
|
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| Participants |
|
|
| Secondary | Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
|
|
|
| Secondary | Number of Participants With AEs Related to Study Procedure or Study Devices | Rate of all AEs related to the procedure or study devices through 1-month follow-up. Rate of all AEs related to the procedure or study devices through 1-month follow-up was also measured based on Common Terminology Criteria for Adverse Events (CTCAE) classification. CTCAE grading is evaluated on a scale from 1-5 (1 - mild; intervention not indicated; 5 - most severe; death related to AE). Subjects could have more than one AE with different CTCAE Grades. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
|
|
|
| Secondary | Number of Participants With SAEs Related to the Study Procedure or Study Devices | Rate of all SAEs related to the procedure or study devices through 1-month follow-up. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) |
|
|
|
| Secondary | Score of Patient Satisfaction, Pain, and Breathlessness | Patient satisfaction, pain, and breathlessness (Bronchoscopic Ablation Patient Pain and Satisfaction Survey) At the 1-month visit, subjects assessed their pain/discomfort and breathlessness based on how they recall feeling at 3 different timepoints. The timepoints were immediately, one week, and one month after the bronchoscopic ablation procedure. Pain or discomfort were evaluated on a scale from 0-10 (10 - severe/interferes with basic needs). Breathlessness was evaluated on a scale from 1-5 (5 - too breathless to leave the house, or breathless when undressing). Subjects also evaluated their willingness to have the procedure performed again on a scale from 1-5 (5 - extremely likely), how likely they would recommend the procedure to family and friends on a scale from 1-5 (5 - extremely likely), and how satisfied they were with the procedure on a scale from 1-5 (5 - extremely satisfied). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | score on a scale | Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure) |
|
|
|
| Secondary | Score of Current Health State From Quality of Life Survey | Quality of life evaluation based on EuroQol [EQ-5D-3L] survey. The questions from the survey surround current health status. The subjects assessed their current health state on a scale of 0-100 (100 being the best health state imaginable). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1-month |
|
|
|
| Secondary | Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol | Technical success: An evaluation of whether the lung nodule was treated according to the study protocol as determined at the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could not be executed completely, either for technical reasons or for reasons related to comorbid disease. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Units | lesions ablated | Immediately post-procedure | lesions ablated | lesions ablated |
|
|
|
| Secondary | Number of Lung Nodules Evaluated as Being Effectively Ablated | Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by CT imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Units | lesions ablated | 1-month follow-up (an average of 20-40 days post-procedure) | lesions ablated | lesions ablated |
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| 20 |
| 30 |
| Post ablation syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Post ablation syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Unwanted awareness during anaesthesia | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural thickening | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
Institution/Investigator shall not publish the Study results until after Sponsor's multi-site publication and final study results are complete or until the elapse of twelve (12) months from the close of the Study at all Study sites, whichever occurs first; unless approved by Sponsor.
| D012140 |
| Respiratory Tract Diseases |
| Left Lower Lobe |
|
| Title | Measurements |
|---|---|
|
| CTCAE Grade 3 |
|
| CTCAE Grade 4 |
|
| CTCAE Grade 5 |
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| Breathlessness immediately after procedure |
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| Breathlessness one week after procedure |
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| Breathlessness one month after procedure |
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| Willingness to have the procedure performed again |
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| Likelihood to recommend the procedure to family and friends |
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| Satisfaction with procedure at 1-month |
|