Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter (NAVABLATE)

Medtronic

Status: Completed

Conditions: Cancer, Lung; Cancer, Metastatic to Lung

Treatments: Device: Bronchoscopic ablation catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT03569111

MDT18010ILSBA

Details and patient eligibility

About

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.

Full 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:

• Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
• Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
• Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
• Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
• Quality of life (EQ-5D Scale)
• Technical success
• Technique efficacy

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is ≥ 18 years of age
2. Subject has provided informed consent
3. Subject is able and willing to comply with the study follow-up schedule
4. Subject has a definitive diagnosis of cancer in the lung
5. Target nodule is ≤ 30mm in maximum diameter
6. There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
7. Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
8. Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
9. Subject is not a candidate for lung surgery or refuses lung surgery
10. Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT

Exclusion criteria

1. Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
2. Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
3. Female subjects who are pregnant or nursing as determined by standard site practices
4. Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
5. The investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Trial design