Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

NCT03272971 | Terminated FDA Device

• 1 other identifier: Protocol 45
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.

Conditions

Lung Cancer; Lung Cancer Metastatic; Lung Cancer, Non-small Cell

Keywords

lung cancer; radiofrequency ablation; bronchoscopy; NSCLC

Outcome Measures

Primary Outcomes (3)

• RFA relate AEs/SAEs

  The incidence of reported adverse events and serious adverse events related to the RFA procedure

  Day 0

• Feasibility - Ablated Tissue

  Semi-quantitative scoring of necrotic tissue assessed by histology

  Day 0

• Feasibility - Delivery of Ablation

  Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.

  Day 0

Study Arms (1)

Radio-frequency Ablation

EXPERIMENTAL

Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.

Device: Radio-frequency Ablation

Interventions

Radio-frequency Ablation DEVICE

The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.

Radio-frequency Ablation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
• Must be eligible for curative lung resection (lobectomy)
• Tumor/lesion size will be a minimum of 10mm along the minor diameter
• Willing to participate in all aspects of study protocol for duration of the study
• Able to understand study requirements
• Signs informed consent form

You may not qualify if:

• Any contraindication to bronchoscopy, for example:
• Untreatable life-threatening arrhythmias.
• Inability to adequately oxygenate the patient during the procedure.
• Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated).
• Recent myocardial infarction.
• Previously diagnosed high-grade tracheal obstruction.
• Uncorrectable coagulopathy
• Known coagulopathy
• Platelet dysfunction or platelet count \<100 x 10\^3 cells/mm3
• History of major bleeding with bronchoscopy
• Suspected pulmonary hypertension: additional testing required, such as ECG
• Moderate-to-severe pulmonary fibrosis
• Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD):
• additional testing and PI consent is required
• Bullae \>5cm located within the same lobe of target tumor/lesion

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 6, 2017
• Study Start: December 5, 2017
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

CN (1)