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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

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.

Condition or disease Intervention/treatment
Lung Diseases Device: Radiofrequency (RF) catheter

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.


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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Group/Cohort Intervention/treatment
Roll-in
Initial patients enrolled until optimal RF algorithm is determined
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

Optimized
Patients treated using optimal RF algorithm
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




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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


Biospecimen Retention:   Samples Without DNA
Fixed lung tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131777


Contacts
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Contact: Julie Arneson, BSc 206 926-7408 jarneson@uptakemedical.com

Sponsors and Collaborators
Broncus Medical Inc
Uptake Medical Technology, Inc.
Investigators
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Principal Investigator: Felix J Herth, MD, PhD Heidelberg University

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Responsible Party: Broncus Medical Inc
ClinicalTrials.gov Identifier: NCT04131777     History of Changes
Other Study ID Numbers: Protocol 46
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases