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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131777
• Other study ID #: Protocol 46
• Status: Recruiting
• Start date: December 9, 2019
• Est. completion date: November 2020

Study information

• Verified date: March 2020
• Source: Broncus Medical Inc
• Contact: Julie Arneson, BSc
• Phone: 206 926-7408
• Email: jarneson[@]uptakemedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Germany	Thoraxklinik Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Broncus Medical Inc	Uptake Medical Technology, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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