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AzTrials

Lung NeoplasmsBRONC-RFⅡNCT04619472

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

A study testing Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter in people with Lung Neoplasms and Pulmonary Metastasis, run by Hangzhou Broncus Medical Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasms, Pulmonary Metastasis
What is being tested?
Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
3 sitesChina
Study dates
7 Jan 2021to 27 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The First Hospital of Peking University

    Beijing, Beijing Municipality, 100000

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: A Multicenter, Single Group Target Value Clinical Study to Evaluate Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors

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.

Read the detailed description

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. During the study, eligible subjects will be followed up intraoperatively, 24 hours after operation, before discharge/ 7 days after operation (whichever occurs first), 30 days (±7 days) after operation, 3 months (±7 days) after operation, 6 months (±15 days) after operation, 9 months (±15 days) after operation, and 12 months (±15 days) after operation.

Being tested
Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter
Keywords
Lung Neoplasms, Radiofrequency ablation, Pulmonary Metastasis, Primary Pulmonary Neoplasms
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation CatheterDevice

    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.

Study groups in NCT04619472
Study groupRoleWhat they receive
Radiofrequency Ablation (RFA)ExperimentalThe 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.
Receives: Device: Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Six months

Secondary outcomes (10)

  1. Technical success rate (in terms of ablation operations)

    It is defined as the proportion that the ablation operations in which the test device is successfully placed at the target lesion and the device is successfully withdrawn after treatment procedure, account for all ablation operations.

    Measured: Immediately after Each Operation

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

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

    Measured: Six months

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

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

    Measured: Six months

  4. Intrapulmonary progression-free survival rate at 6 months

    Six months after overall ablation procedure, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.

    Measured: Six months

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

    Twelve months after the completion of the overall ablation, the proportion that lesions which maintain completely ablated account for all evaluable lesions that receive radiofrequency ablation.

    Measured: Twelve months

  6. Complete ablation rate at 12 months (in terms of subjects)

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

    Measured: Twelve months

  7. Intrapulmonary progression-free survival rate at 1 year

    Twelve months after the completion of the overall ablation, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.

    Measured: Twelve months

  8. Overall survival rate (OS) at 1 year

    It is defined as the proportion of surviving subjects at 1 year from enrollment.

    Measured: Twelve months

  9. Quality of life (QoL)

    The QoL changes are evaluated according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ C30) assessment scale during the follow-up. The EORCT QLQ C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.

    Measured: Twelve months

  10. Safety

    All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0 (if applicable). Related and possible related AEs and SAEs will be determined and evaluated.

    Measured: Twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start7 Jan 2021
  3. Primary completion24 Oct 2022
  4. Study completion27 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619472
Sponsor's protocol ID
BC-RF-01
Acronym
BRONC-RFⅡ
Status last verified
Apr 2023
First submitted
2 Nov 2020
Last updated
22 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhong C, Chen E, Su Z, Chen D, Wang F, Wang X, Liu G, Zhang X, Luo F, Zhang N, Wang H, Jin L, Long F, Liu C, Wu S, Geng Q, Wang X, Tang C, Chen R, Herth FJF, Sun J, Li S. Safety and efficacy of a novel transbronchial radiofrequency ablation system for lung tumours: One year follow-up from the first multi-centre large-scale clinical trial (BRONC-RFII). Respirology. 2025 Jan;30(1):51-61. doi: 10.1111/resp.14822. Epub 2024 Aug 28.

    PubMed 39197870

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter in people with Lung Neoplasms and Pulmonary Metastasis, run by Hangzhou Broncus Medical Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete ablation rate of main lesions at 6 months (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619472, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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