Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors

NCT04619472 | Completed

• 1 other identifier: BC-RF-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

It is a multicenter, single group target value clinical trial to evaluate the safety and effectiveness of radiofrequency ablation for peripheral lung tumors under the conjunction of the pulmonary radiofrequency ablation system with the disposable pulmonary radiofrequency ablation catheter developed by Hangzhou Broncus Medical Co., Ltd.

Conditions

Lung Neoplasms; Pulmonary Metastasis

Keywords

Lung Neoplasms; Radiofrequency ablation; Pulmonary Metastasis; Primary Pulmonary Neoplasms

Outcome Measures

Primary Outcomes (1)

• Complete ablation rate of main lesions at 6 months

  Six months after the overall ablation procedure, the proportion that subjects whose main lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.

  Six months

Secondary Outcomes (10)

• Technical success rate (in terms of ablation operations)

  Immediately after Each Operation

• Complete ablation rate at 6 months (in terms of ablation lesions)

  Six months

• Complete ablation rate at 6 months (in terms of subjects)

  Six months

• Intrapulmonary progression-free survival rate at 6 months

  Six months

• Complete ablation rate at 12 months (in terms of ablation lesions)

  Twelve months

Study Arms (1)

Radiofrequency Ablation (RFA)

EXPERIMENTAL

The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter.

Device: Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter

Interventions

Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter DEVICE

The conjunction of the pulmonary RFA system with the disposable pulmonary RFA catheter developed by Hangzhou Broncus Medical Co., Ltd. is aim to specifically target lung tumors. The ablation catheter is designed to reach the tumor through the bronchial pathway.

Radiofrequency Ablation (RFA)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old;
• Planned ablated main lesions are pathologically confirmed and other planned ablated lesions are pathologically confirmed or clinical evaluated as primary NSCLC or pulmonary metastasis, and the primary lesions of lung metastasis subjects has been well controlled;
• Number of unilateral lung lesions: ≤ 3 (excepting for multiple primary lung cancers);
• Each lung lesion in size: ≤3 cm ;
• Subjects refuse surgery or are considered intolerant of surgery;
• Subjects refuse or are considered unsuitable for radiotherapy/chemotherapy, or are non-responders for previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy;
• It is feasible to arrive at the target lesions through bronchus path and carry out ablation operations, assessed by investigators;
• Subjects whose Eastern oncology cooperative group (ECOG) physical state score: ≤3;
• Subjects agree to undergo radiofrequency ablation to treat pulmonary lesions.

You may not qualify if:

• Subjects with severe bleeding tendency and irreversible clotting disorders; or subjects who have stopped anticoagulation therapy and/or antiplatelet drugs for less than 7 days before ablation;
• Subjects whose preoperative examination within 1 month shows intrathoracic lymph node or extra-pulmonary metastasis (except for extra-pulmonary metastasis controlled by local therapy);
• Planned ablated lesions have received radiotherapy within past 6 months;
• Subjects with high-risk disease for ablation operation;
• The nearest distance between the tumors and trachea, main bronchial tube, esophagus, aortic arch branch, main pulmonary artery, left and right pulmonary artery and the heart is less than 2cm;
• Subjects who have participated in the last 30 days or is participating in other clinical studies;
• Subjects who are pregnant or have pregnancy plan during the study;
• Subjects with bronchoscopy contraindications;
• Subjects with implantable cardiac pacemakers, implantable defibrillators, or other active implants;
• Subjects with general anesthesia contraindications;
• Subjects with other conditions that need to be excluded as determined by investigators.

Sponsors & Collaborators

• Hangzhou Broncus Medical Co., Ltd.: lead

Study Sites (3)

The First Hospital of Peking University

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shiyue Li, MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: January 7, 2021
• Primary Completion: October 24, 2022
• Study Completion: March 27, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)