COPDNCT05799664
Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD
A study testing TLD in people with COPD, run by Hangzhou Broncus Medical Co., Ltd. at 1 site in China.
Trial summary
The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- TLD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥40 and ≤ 85 years;
- Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1<30%pred, PaCO2≤50mmHg;
- CAT ≥ 10 or mMRC ≥2;
- Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;
- Recent participation in a formal pulmonary rehabilitation program should have occurred ≥3 months prior to consent; if participants are currently enrolled in a maintenance program, they should agree to continue their current program through their 12-month follow-up visit;
- Documented history of taking standard medication (consistent with GOLD guideline<2022>) for ≥12 months at the time of consent;
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- Received an influenza vaccine within the 12 months prior to consent or agrees to obtain an influenza vaccine during the clinical investigation, and agrees to annual influenza vaccines for the duration of the clinical investigation;
- Resting SpO2 ≥ 89% at the time of screening;
- Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary;
- Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.
Who cannot join
- BMI < 18 or > 35;
- Asthma as defined by the GINA guideline (2022);
- Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis);
- Patient has a medical history of pneumothorax within 6 months before the screening visit;
- Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled;
- Recent respiratory infections or COPD exacerbation in preceding 4 weeks;
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- Malignancy treated with radiation or chemotherapy within 2 years of consent;
- Daily use of > 10 mg of prednisone or its equivalent at the time of consent;
- Recent (within 3 months of consent) opioid use;
- Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas
- Has an implantable electronic device;
- Previous or planned pulmonary or thoracic surgery (including pneumonectomy, lung transplantation, bronchoscopic/interventional lung volume reduction procedures < e.g. endobronchial valve implantation or bronchial thermal vapor ablation, etc.>) during this trial;
- Myocardial infarction within last 6 months, EKG with evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF < 45%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure, or any other cardiac findings that make the participant an unacceptable candidate for a bronchoscopic procedure utilizing general anesthesia;
- High risk of pulmonary hypertension according to clinical assessment, defined as pulmonary artery systolic pressure estimated by echocardiogram to be > 50 mmHg;
- A lesion highly suspicious for malignancy in the lung or elsewhere, as determined by a specialist, that is expected to require surgery or systemic anticancer therapy within 1 year.;
- Clinically relevant bronchiectasis, defined as severe single lobe or multilobar bronchial wall thickening associated with airway dilation on CT scan leading to cough, intractable expectoration and repeated hemoptysis lasting for several days;
- In the opinion of the Investigator, use of the TLD devices is not feasible, for example, due to screening chest CT scan reveals severe emphysema or bronchi anatomy cannot be fully treated with available catheter sizes: severe bullous disease (> 1/3 hemithorax) or site discovery of a mass that requires treatment;
- A GCSI total symptom score ≥ 18.0 prior to treatment;
- Any disease or condition that might interfere with completion of a procedure or this study (e.g., life expectancy< 1 years);
- Women of childbearing potential must have a negative pregnancy test (blood or urine) pre-treatment and agree not to become pregnant for the duration of the study
- Participated in any clinical trial and received experimental treatment within 3 months before the screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Fengming Luo, M.D, +8618980601355, luofengming@hotmail.com
Fengming Luo, M.D.
About this study
Official title: A Multicenter, Randomized, Single-blind, Sham-controlled Clinical Trial to Evaluate the Safety and Effectiveness of Targeted Lung Denervation Radiofrequency Ablation Devices in the Treatment of Chronic Obstructive Pulmonary Disease
The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device.
- Conditions
- COPD
- Being tested
- TLD, Sham TLD procedure, Standard of care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLDDevice
Patients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy.
Sham TLD procedureOther
Patients allocated to control group will receive sham TLD procedure during which catheter will be placed in all treatment locations with no radiofrequency energy delivered.
Standard of careOther
Patients will also receive standard of care that meet the recommendations of GOLD guideline.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will be treated with TLD and standard of care (per GOLD guideline). Receives: Device: TLD; Other: Standard of care |
| Control group | Sham comparator | Patients will undergo sham TLD procedure and be treated with standard of care (per GOLD guideline). Receives: Other: Sham TLD procedure; Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Forced expiratory volume in first second (FEV1) relative to baseline
Defined as change in FEV1 at 6 months relative to baseline in the experimental group, compared to the control group.
Measured: 6 Months
Secondary outcomes (8)
Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization.
Defined as a comparison between study arms of the survival distributions for events based on log-rank tests.
Measured: 12 Months
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score
Defined as a comparison between study arms of the mean change in SGRQ-C from baseline.
The SGRQ-C is a questionnaire developed to measure health status (quality of life) in COPD patients with a total and three component scores for: symptoms, activity and impacts; each score ranges from 0 (no impairment) to 100 (worst possible).
Measured: 6 and 12 Months
Change in modified Medical Research Council (mMRC) scale Total score
Defined as a comparison between study arms of the mean change in mMRC from baseline.
The modified Medical Research Council (mMRC) scale is recommended for conducting assessments of dyspnea and disability and functions. Total score ranging 0 to 4. The higher the score, the more deterioration in severity of dyspnea.
Measured: 6 and 12 Months
Change in COPD Assessment Test (CAT) Total score
Defined as a comparison between study arms of the mean change in CAT from baseline.
The CAT is a disease-specific HRQL with eight questions; each score ranges from 0 (no impairment) to 5 (worst possible). The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: 6 and 12 Months
Change in Pulmonary Function
Defined as a comparison between study arms of the mean change in FEV1%pred, FVC(%pred), RV(%pred) from baseline.
Measured: 6 and 12 Months
Change in 6-minute walk distance (6MWD)
Defined as a comparison between study arms of the mean change in 6MWD from baseline.
Measured: 6 and 12 Months
Device Success Rate of experimental group
Defined as the proportion of the number of ablation procedures in which the catheter would be successfully placed on the treatment site and the catheter would be successfully withdrawn after the completion of the treatment procedure in all the ablation procedures.
Measured: Immediately after the procedure
(Serious) Adverse Event Rate related to device or procedure
Defined as the total number of events per total number of treatment years.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start4 Jul 2023
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengming Luo, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799664
- Sponsor's protocol ID
- BC-TLD-02
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Sham-controlled Clinical Trial to Evaluate the Safety and Effectiveness of Targeted Lung Denervation Radiofrequency Ablation Devices in the Treatment of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05799664
- Acronym / sponsor ID
- BC-TLD-02
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: TLD, Other: Standard of carePatients will be treated with TLD and standard of care (per GOLD guideline). |
| Control group | Sham comparator | Other: Sham TLD procedure, Other: Standard of carePatients will undergo sham TLD procedure and be treated with standard of care (per GOLD guideline). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants aged ≥40 and ≤ 85 years;
- Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1<30%pred, PaCO2≤50mmHg;
- CAT ≥ 10 or mMRC ≥2;
- Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;
- Recent participation in a formal pulmonary rehabilitation program should have occurred ≥3 months prior to consent; if participants are currently enrolled in a maintenance program, they should agree to continue their current program through their 12-month follow-up visit;
Key exclusion criteria (21 listed)
- BMI < 18 or > 35;
- Asthma as defined by the GINA guideline (2022);
- Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis);
- Patient has a medical history of pneumothorax within 6 months before the screening visit;
- Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLDPatients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy. | Device | Experimental group |
| Sham TLD procedurePatients allocated to control group will receive sham TLD procedure during which catheter will be placed in all treatment locations with no radiofrequency energy delivered. | Other | Control group |
| Standard of carePatients will also receive standard of care that meet the recommendations of GOLD guideline. | Other | Control group, Experimental group |
Primary outcome
Change of Forced expiratory volume in first second (FEV1) relative to baseline
Time frame: 6 Months
Defined as change in FEV1 at 6 months relative to baseline in the experimental group, compared to the control group.
8 secondary outcomes
Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization.
Time frame: 12 Months
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score
Time frame: 6 and 12 Months
Change in modified Medical Research Council (mMRC) scale Total score
Time frame: 6 and 12 Months
Change in COPD Assessment Test (CAT) Total score
Time frame: 6 and 12 Months
Change in Pulmonary Function
Time frame: 6 and 12 Months
Change in 6-minute walk distance (6MWD)
Time frame: 6 and 12 Months
Device Success Rate of experimental group
Time frame: Immediately after the procedure
(Serious) Adverse Event Rate related to device or procedure
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fengming Luo, M.D. principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLD in people with COPD, run by Hangzhou Broncus Medical Co., Ltd. at 1 site 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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liheng Xie (+8613916444591, medicalaffairs@broncuschina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Forced expiratory volume in first second (FEV1) relative to baseline (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.