Status:
UNKNOWN
Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
Lead Sponsor:
Broncus Medical Inc
Collaborating Sponsors:
Uptake Medical Technology, Inc.
Conditions:
Lung Diseases
Eligibility:
All Genders
18+ years
Brief Summary
A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lun...
Detailed Description
This study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (RF) ablation treatment malignant lung lesions prior to surgical resection. Up to 15 patients ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at screening
- Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
- Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
- Tumor/lesion \> 2cm along the major diameter with no visible necrosis
- Signed informed consent form
Exclusion
- An implantable pacemaker, defibrillator, or other active implants
- Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation
Key Trial Info
Start Date :
December 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04131777
Start Date
December 9 2019
End Date
November 1 2020
Last Update
March 27 2020
Active Locations (1)
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1
Thoraxklinik Heidelberg
Heidelberg, Germany