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Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
trial testing Bronchoscopic ablation catheter in Cancer, Lung in 30 participants. Completed in 28 October 2020.
| Lead sponsor | Medtronic - MITG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 27 February 2019 |
| Primary completion | 28 October 2020 |
| Estimated completion | 28 October 2020 |
| Sites | 2 locations across Hong Kong, United Kingdom |
Medtronic - MITG — full company profile →
18 and older, any sex, with Cancer, Lung or Cancer, Metastatic to Lung. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-Arm Study) | 1 |
Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 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.
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 21 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 15 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 11 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 4 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 0 |
Rate of all SAEs related to the procedure or study devices through 1-month follow-up.
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 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 thei
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 1.5 | ± 2.2 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 1.4 | ± 1.8 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 0.5 | ± 1.1 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 1.8 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 1.6 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 1.5 | ± 0.9 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 4.8 | ± 0.8 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 4.9 | ± 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).
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 74.6 | ± 12.8 |
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 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.
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 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).
| Group | Value | 95% CI |
|---|---|---|
| NAVABLATE (Single-arm Study) | 30 |
Time frame: 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.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NAVABLATE (Single-arm Study) |
|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Administration site infection | Infections and infestations | — |
| Post ablation syndrome | Injury, poisoning and procedural complications | — |
| Post procedural inflammation | Injury, poisoning and procedural complications | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | NAVABLATE (Single-arm Study) |
|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Chest discomfort | General disorders | — |
| Lower respiratory tract infection | Infections and infestations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Bradycardia | Cardiac disorders | — |
| Post ablation syndrome | Injury, poisoning and procedural complications | — |
| Unwanted awareness during anaesthesia | Injury, poisoning and procedural complications | — |
| Pleural thickening | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Procedural pain, Pleural effusion, Administration site infection, Post ablation syndrome, Post procedural inflammation, Dyspnoea, Haemoptysis.
Data from ClinicalTrials.gov NCT03569111 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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