N/A
Completed N=30
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
Cancer, Lung · Cancer, Metastatic to Lung
Source: ClinicalTrials.gov NCT03569111 ↗
Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Nov 2022
Primary outcomePrimary: Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology |
1 | — |
| SECONDARY Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology |
— | — |
| SECONDARY Number of Participants With AEs Related to Study Procedure or Study Devices |
21; 15; 11; 4; 0; 0 | — |
| SECONDARY Number of Participants With SAEs Related to the Study Procedure or Study Devices |
4 | — |
| SECONDARY Score of Patient Satisfaction, Pain, and Breathlessness |
1.5; 1.4; 0.5; 1.8; 1.6; 1.5 | — |
| SECONDARY Score of Current Health State From Quality of Life Survey |
74.6; 77.4 | — |
| SECONDARY Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol |
30 | — |
| SECONDARY Number of Lung Nodules Evaluated as Being Effectively Ablated |
30 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is ≥ 18 years of age
- Subject has provided informed consent
- Subject is able and willing to comply with the study follow-up schedule
- Subject has a definitive diagnosis of cancer in the lung
- Target nodule is ≤ 30mm in maximum diameter
- There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
- Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
- Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
- Subject is not a candidate for lung surgery or refuses lung surgery
- Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT
Exclusion Criteria
- Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
- Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
- Female subjects who are pregnant or nursing as determined by standard site practices
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- The investigator determines that participation in the study may jeopardize the safety or welfare of the subject
Data sourced from ClinicalTrials.gov (NCT03569111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.