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

NCT05799664 | Recruiting

• 1 other identifier: BC-TLD-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (8)

• Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization.

  12 Months

• Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score

  6 and 12 Months

• Change in modified Medical Research Council (mMRC) scale Total score

  6 and 12 Months

• Change in COPD Assessment Test (CAT) Total score

  6 and 12 Months

• Change in Pulmonary Function

  6 and 12 Months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

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).

Other: Sham TLD procedure; Other: Standard of care

Interventions

TLD DEVICE

Patients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy.

Experimental group

Sham TLD procedure OTHER

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.

Control group

Standard of care OTHER

Patients will also receive standard of care that meet the recommendations of GOLD guideline.

Control group; Experimental group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged ≥40 and ≤ 75 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;
• 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.

You may not qualify if:

• 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;
• 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;
• 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 but not limited to: pneumonectomy, lung transplantation, pulmonary medical device intervention \< e.g. pulmonary valve implantation, bronchial thermal ablation (BT), 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;
• Pulmonary nodule or other lesions thought to be at high risk of malignancy;

Sponsors & Collaborators

• Hangzhou Broncus Medical Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fengming Luo, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liheng Xie

CONTACT

+8613916444591; medicalaffairs@broncuschina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 5, 2023
• Study Start: July 4, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)