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Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung

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ClinicalTrials.gov Identifier: NCT04131777
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Uptake Medical Technology, Inc.
Information provided by (Responsible Party):
Broncus Medical Inc

Tracking Information
First Submitted Date October 9, 2019
First Posted Date October 18, 2019
Last Update Posted Date October 18, 2019
Estimated Study Start Date October 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2019)
  • Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion [ Time Frame: The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care ]
    Maximum diameter (in mm) of ablation zone (thermal necrosis) surrounding treated lesion as measured in resected tissue by quantitative histopathological and gross pathological analysis
  • Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use [ Time Frame: Assessed at the time of the RF ablation procedure ]
    The ability of the ablation treatment to be delivered as per the Instructions for Use will be assessed using a binary categorical scale (yes/no)
  • Safety - Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: AEs and SAEs related to the RF procedure/device will be reported for the interval beginning with the RF ablation procedure and ending with the surgical resection of the ablated lung tissueion ]
    The incidence of reported adverse events and serious adverse events related to the RF ablation procedure/device
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
Official Title Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
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 lung cancer or metastatic lung lesions who are scheduled for surgical resection.
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 will be treated at the participating sites.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Fixed lung tissue
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with non-small cell lung cancer (NSCLC) and/or pulmonary metastases that are recommended for curative lung resection (pneumonectomy, lobectomy). Enrolled patients will have a microscopically confirmed malignancy, ensuring patients are surgical candidates.
Condition Lung Diseases
Intervention Device: 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 Name: EMPOWER® RF Catheter
Study Groups/Cohorts
  • Roll-in
    Initial patients enrolled until optimal RF algorithm is determined
    Intervention: Device: Radiofrequency (RF) catheter
  • Optimized
    Patients treated using optimal RF algorithm
    Intervention: Device: Radiofrequency (RF) catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 16, 2019)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age ≥ 18 years at screening
  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:

  1. An implantable pacemaker, defibrillator, or other active implants
  2. Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Julie Arneson, BSc 206 926-7408 jarneson@uptakemedical.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04131777
Other Study ID Numbers Protocol 46
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Broncus Medical Inc
Study Sponsor Broncus Medical Inc
Collaborators Uptake Medical Technology, Inc.
Investigators
Principal Investigator: Felix J Herth, MD, PhD Heidelberg University
PRS Account Broncus Medical Inc
Verification Date October 2019