Clinical trial · Observational
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Metastatic to Lung | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bronchoscopic ablation catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
- timeFrame
- During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
- description
- 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.
Secondary outcomes (7)
- measure
- Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
- timeFrame
- During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
- description
- Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
- measure
- Number of Participants With AEs Related to Study Procedure or Study Devices
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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