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

NCT04131777 | Unknown FDA Device

• 1 other identifier: Protocol 46
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Roll-in

Initial patients enrolled until optimal RF algorithm is determined

Device: Radiofrequency (RF) catheter

Optimized

Patients treated using optimal RF algorithm

Device: Radiofrequency (RF) catheter

Interventions

Radiofrequency (RF) catheter DEVICE

A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation

Also known as: EMPOWER® RF Catheter

Optimized; Roll-in

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years at screening
• Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
• Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
• Tumor/lesion \> 2cm along the major diameter with no visible necrosis
• Signed informed consent form

You may not qualify if:

• An implantable pacemaker, defibrillator, or other active implants
• Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation

Sponsors & Collaborators

• Broncus Medical Inc: lead
• Uptake Medical Technology, Inc.: collaborator

Study Sites (1)

Thoraxklinik Heidelberg

Heidelberg, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed lung tissue

MeSH Terms

Conditions

Lung Diseases

Interventions

Catheters

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Felix J Herth, MD, PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Arneson, BSc

CONTACT

206 926-7408; jarneson@uptakemedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 18, 2019
• Study Start: December 9, 2019
• Primary Completion: August 1, 2020
• Study Completion: November 1, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)