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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Diseases
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Julie Arneson, BSc; Phone Number: 206 926-7408; Email: jarneson@uptakemedical.com

Study Locations

• Germany
  • Heidelberg, Germany
    • Recruiting
    • Thoraxklinik Heidelberg
    • Principal Investigator: Felix Herth, MD PhD
    • Contact: Michaela Korthoeber, Coordinator; Phone Number: +49 6221 396 8253; Email: michaela.korthoeber@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: EMPOWER® RF Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion	Maximum diameter (in mm) of ablation zone (thermal necrosis) surrounding treated lesion as measured in resected tissue by quantitative histopathological and gross pathological analysis	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
Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use	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)	Assessed at the time of the RF ablation procedure
Safety - Adverse events (AEs) and serious adverse events (SAEs)	The incidence of reported adverse events and serious adverse events related to the RF ablation procedure/device	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Protocol 46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes