Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD

Broncus Medical

Status: Enrolling

Conditions: COPD

Treatments: Other: Standard of care; Device: TLD; Other: Sham TLD procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT05799664

BC-TLD-02

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants aged ≥40 and ≤ 75 years;
2. Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1<30%pred, PaCO2≤50mmHg;
3. CAT ≥ 10 or mMRC ≥2;
4. Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;
5. 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;
6. Documented history of taking standard medication (consistent with GOLD guideline<2022>) for ≥12 months at the time of consent;
7. 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;
8. Resting SpO2 ≥ 89% at the time of screening;
9. Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary;
10. Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.

Exclusion criteria

1. BMI < 18 or > 35;
2. Asthma as defined by the GINA guideline (2022);
3. Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis);
4. Patient has a medical history of pneumothorax;
5. Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled;
6. Recent respiratory infections or COPD exacerbation in preceding 4 weeks;
7. Malignancy treated with radiation or chemotherapy within 2 years of consent;
8. Daily use of > 10 mg of prednisone or its equivalent at the time of consent;
9. Recent (within 3 months of consent) opioid use;
10. Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas
11. Has an implantable electronic device;
12. Previous or planned pulmonary or thoracic surgery (including but not limited to: pneumonectomy, lung transplantation, pulmonary medical device intervention < e.g. pulmonary valve implantation, bronchial thermal ablation (BT), etc. >) during this trial;
13. 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;
14. High risk of pulmonary hypertension according to clinical assessment, defined as pulmonary artery systolic pressure estimated by echocardiogram to be > 50 mmHg;
15. Pulmonary nodule or other lesions thought to be at high risk of malignancy;
16. 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;
17. 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;
18. A GCSI total symptom score ≥ 18.0 prior to treatment;
19. Any disease or condition that might interfere with completion of a procedure or this study (e.g., life expectancy< 1 years);
20. 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
21. Participated in any clinical trial and received experimental treatment within 3 months before the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Experimental group

Experimental group

Description:

Patients will be treated with TLD and standard of care (per GOLD guideline).

Treatment:

Device: TLD

Other: Standard of care

Control group

Sham Comparator group

Description:

Patients will undergo sham TLD procedure and be treated with standard of care (per GOLD guideline).

Treatment:

Other: Sham TLD procedure

Other: Standard of care