NAVABLATE: Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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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Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
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Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
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Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
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Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
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Quality of life (EQ-5D Scale)
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Technical success
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Technique efficacy
Study Design
Outcome Measures
Primary Outcome Measures
- Characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology (AEs related to study device) [1-month]
The primary endpoint is the composite rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
Secondary Outcome Measures
- SAEs related to study device [1-month]
Composite rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
- AEs related to study procedure [1-month]
Composite rate of all AEs related to the procedure or study devices through 1-month follow-up.
- SAEs related to study procedure [1-month]
Composite rate of all SAEs related to the procedure or study devices through 1-month follow-up.
- Patient Survey [1-month]
Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
- Quality of Life (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression, health state) [1-month]
Quality of life evaluation (EuroQol [EQ-5D]). The questions from the survey surround current health status. There are 5 questions where the response options get worse as they go in regards to different aspects of the subject's health status. The last question asks on a scale of 0-100, the current health state (100 being the best health state imaginable)
- Technical Success [Post-procedure]
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.
- Technique Efficacy [1-month]
Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is ≥ 18 years of age
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Subject has provided informed consent
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Subject is able and willing to comply with the study follow-up schedule
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Subject has a definitive diagnosis of cancer in the lung
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Target nodule is ≤ 30mm in maximum diameter
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There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
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Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
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Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
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Subject is not a candidate for lung surgery or refuses lung surgery
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Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT
Exclusion Criteria:
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Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
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Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
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Female subjects who are pregnant or nursing as determined by standard site practices
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Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
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The investigator determines that participation in the study may jeopardize the safety or welfare of the subject
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prince of Wales Hospital | Hong Kong | Hong Kong | ||
| 2 | St. Bartholomew's Hospital | London | United Kingdom |
Sponsors and Collaborators
- Medtronic - MITG
Investigators
- Principal Investigator: Kelvin Lau, MA DPhil FRCS(CTh), St Bartholomew's Hosptial
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT18010ILSBA