- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619472
Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors (BRONC-RFⅡ)
December 19, 2023 updated by: Hangzhou Broncus Medical Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rongguang Jin, MA
- Phone Number: 86-13524808792
- Email: lincy.jin@dnamedtech.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100000
- The First Hospital of Peking University
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Guangdong
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Guangzhou, Guangdong, China, 510000
- The First Affiliated Hospital of Guangzhou Medical University
-
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Shanghai
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Shanghai, Shanghai, China, 200000
- Shanghai Chest Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiofrequency Ablation (RFA)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete ablation rate of main lesions at 6 months
Time Frame: Six 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success rate (in terms of ablation operations)
Time Frame: Immediately after Each Operation
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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.
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Immediately after Each Operation
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Complete ablation rate at 6 months (in terms of ablation lesions)
Time Frame: Six months
|
Six months after overall ablation procedure, the proportion that lesions completely ablated account for all evaluable lesions that receive radiofrequency ablation.
|
Six months
|
Complete ablation rate at 6 months (in terms of subjects)
Time Frame: Six months
|
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.
|
Six months
|
Intrapulmonary progression-free survival rate at 6 months
Time Frame: Six months
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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.
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Six months
|
Complete ablation rate at 12 months (in terms of ablation lesions)
Time Frame: Twelve months
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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.
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Twelve months
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Complete ablation rate at 12 months (in terms of subjects)
Time Frame: Twelve months
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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.
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Twelve months
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Intrapulmonary progression-free survival rate at 1 year
Time Frame: Twelve months
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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.
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Twelve months
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Overall survival rate (OS) at 1 year
Time Frame: Twelve months
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It is defined as the proportion of surviving subjects at 1 year from enrollment.
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Twelve months
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Quality of life (QoL)
Time Frame: Twelve months
|
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.
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Twelve months
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Safety
Time Frame: Twelve months
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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.
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Twelve months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shiyue Li, MD, The First Affiliated Hospital of Guangzhou Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2021
Primary Completion (Actual)
October 24, 2022
Study Completion (Actual)
March 27, 2023
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
November 2, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-RF-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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