Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
NCT ID: NCT04131777
Last Updated: 2020-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2019-12-09
2020-11-30
Brief Summary
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Detailed Description
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Patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. The RF ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. The patients exits the study following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Roll-in
Initial patients enrolled until optimal RF algorithm is determined
Radiofrequency (RF) catheter
A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation
Optimized
Patients treated using optimal RF algorithm
Radiofrequency (RF) catheter
A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation
Interventions
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Radiofrequency (RF) catheter
A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
3. Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
4. Tumor/lesion \> 2cm along the major diameter with no visible necrosis
5. Signed informed consent form
Exclusion Criteria
2. Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation
18 Years
ALL
No
Sponsors
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Uptake Medical Technology, Inc.
INDUSTRY
Broncus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Felix J Herth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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Thoraxklinik Heidelberg
Heidelberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Protocol 46
Identifier Type: -
Identifier Source: org_study_id
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