NAVABLATE
Research type
Research Study
Full title
Clinical description of a bronchoscopic approach to ablate lung nodules using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.
IRAS ID
248536
Contact name
Kelvin K.W. Lau
Contact email
Sponsor organisation
Medtronic Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Summary of Research
The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use.
Summary of Results
Thirty subjects (30 nodules) were enrolled at 2 centers in the United Kingdom (16 subjects) and Hong Kong (14 subjects) between February 2019 and September 2020. All lung nodules had a histologically confirmed malignant diagnosis and all subjects had either declined, or were ineligible for, both surgical lung resection and SBRT. All adverse events related to the Emprint™ Ablation Catheter with Thermosphere™ Technology were graded for severity based on the Common Terminology Criteria for Adverse Events (CTCAE).
The primary safety endpoint (composite serious or non-serious adverse events related to the Emprint™ ablation catheter) rate through one-month follow-up was 3.3% (one patient with mild hemoptysis, Grade 1, non-serious). There were no serious adverse events related to the ablation device. Nine serious adverse events in four patients (13.3%) were considered related to the study procedure or other study devices. A total of 51 adverse events were reported in 21 patients (70%; including 29 Grade 1 events, 13 Grade 2 events, 9 Grade 3 events). There were no deaths or pneumothoraces.
Procedure-day technical success (target nodule treated according to the study protocol) was 100% (30/30), with a mean ablative margin of 9.9±2.7mm. Based on one-month imaging, complete ablation of the nodule (technique efficacy) was achieved in 100% (30/30).
Conclusions: The study results characterize the safety and performance of bronchoscopic microwave ablation for malignant lung nodules ≤30mm in patients declining or not candidates for surgery and SBRT. The safety of the Emprint™ Ablation Catheter is supported by a low (3.3%) rate of adverse events related to the study device, no deaths or pneumothoraces, and no serious adverse events related to the study device. The performance of the Emprint™ Ablation Catheter is supported by 100% procedure-day technical success and 100% technique efficacy at one-month follow-up.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1584
Date of REC Opinion
27 Sep 2018
REC opinion
Further Information Favourable Opinion