An observational study in Cancer, Lung and Cancer, Metastatic to Lung, sponsored by Medtronic - MITG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Medtronic - MITG · Observational
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:
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 30 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
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.
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 1-month follow-up (an average of 20-40 days post-procedure)
| Milestone | NAVABLATE (Single-arm Study) |
|---|---|
| Started | 30 |
| Procedure | 30 |
| 1-month | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| Participants | NAVABLATE (Single-Arm Study) |
|---|---|
| Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | 1 |
Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
| Participants | NAVABLATE (Single-arm Study) |
|---|---|
| Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | 0 |
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.
| Participants | NAVABLATE (Single-arm Study) |
|---|---|
| Composite rate of all AEs related to the procedure or study devices | 21 |
| CTCAE Grade 1 | 15 |
| CTCAE Grade 2 | 11 |
| CTCAE Grade 3 | 4 |
| CTCAE Grade 4 | 0 |
| CTCAE Grade 5 | 0 |
Rate of all SAEs related to the procedure or study devices through 1-month follow-up.
| Participants | NAVABLATE (Single-arm Study) |
|---|---|
| Number of Participants With SAEs Related to the Study Procedure or Study Devices | 4 |
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).
| score on a scale | NAVABLATE (Single-arm Study) |
|---|---|
| Pain/discomfort immediately after procedure | 1.5 ± 2.2 |
| Pain/discomfort one week after procedure | 1.4 ± 1.8 |
| Pain/discomfort one month after procedure | 0.5 ± 1.1 |
| Breathlessness immediately after procedure | 1.8 ± 1.0 |
| Breathlessness one week after procedure | 1.6 ± 1.0 |
| Breathlessness one month after procedure | 1.5 ± 0.9 |
| Willingness to have the procedure performed again | 4.8 ± 0.8 |
| Likelihood to recommend the procedure to family and friends | 4.9 ± 0.4 |
| Satisfaction with procedure at 1-month | 4.8 ± 0.4 |
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).
| score on a scale | NAVABLATE (Single-arm Study) |
|---|---|
| Baseline | 74.6 ± 12.8 |
| 1-month | 77.4 ± 14.2 |
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.
| lesions ablated | NAVABLATE (Single-arm Study) |
|---|---|
| Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol | 30 |
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).
| lesions ablated | NAVABLATE (Single-arm Study) |
|---|---|
| Number of Lung Nodules Evaluated as Being Effectively Ablated | 30 |
Collected over 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.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NAVABLATE (Single-arm Study) | 0/30 (0%) | 4/30 (13.3%) | 20/30 (66.7%) |
| Event | NAVABLATE (Single-arm Study) |
|---|---|
| Procedural painInjury, poisoning and procedural complications | 2/30 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/30 |
| Administration site infectionInfections and infestations | 1/30 |
| Post ablation syndromeInjury, poisoning and procedural complications | 1/30 |
| Post procedural inflammationInjury, poisoning and procedural complications | 1/30 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/30 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 1/30 |
| Event | NAVABLATE (Single-arm Study) |
|---|---|
| Procedural painInjury, poisoning and procedural complications | 13/30 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 7/30 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 5/30 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/30 |
| Chest discomfortGeneral disorders | 2/30 |
| Lower respiratory tract infectionInfections and infestations | 2/30 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/30 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/30 |
| BradycardiaCardiac disorders | 1/30 |
| Post ablation syndromeInjury, poisoning and procedural complications | 1/30 |
30 subjects were enrolled. The bronchoscopic ablation procedure was performed on 1 lesion for each subject.
| Age, Categorical(Participants) | NAVABLATE (Single-arm Study) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 19 |
| Age, Continuous(Years) | NAVABLATE (Single-arm Study) |
|---|---|
| Mean | 68.4 ± 10.3 |
| Sex: Female, Male(Participants) | NAVABLATE (Single-arm Study) |
|---|---|
| Female | 12 |
| Male | 18 |
| Race and Ethnicity Not Collected(Participants) | NAVABLATE (Single-arm Study) |
|---|
| Region of Enrollment(Participants) | NAVABLATE (Single-arm Study) |
|---|---|
| Hong Kong | 14 |
| United Kingdom | 16 |
| Chronic obstructive pulmonary disease(Participants) | NAVABLATE (Single-arm Study) |
|---|---|
| Count of participants | 10 |
| Tobacco use (current or former)(Participants) | NAVABLATE (Single-arm Study) |
|---|---|
| Count of participants | 20 |
| Prior lung procedures performed(Participants) | NAVABLATE (Single-arm Study) |
|---|---|
| Lung surgery | 11 |
| Radiotherapy | 1 |
| Non-surgical biopsy procedure | 19 |
8 further baseline measures are reported on the registry.
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