Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

NCT07468617 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 032
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Chronic Bronchitis

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; CB; Metered Cryospray; Cryospray; RejuvenAir System

Outcome Measures

Primary Outcomes (1)

• Completed MCS treatment applications

  Completed MCS treatment applications at Treatment 1 and Treatment 2 defined as \> or = to 80% of fully delivered MCS applications at each procedure. \[Percent of full vs. total applications at each procedure\].

  Treatment 1 and Treatment 2

Secondary Outcomes (4)

• The number of serious device-related adverse events

  Total events within 30 days of Treatment 1 and Treatment 2

• The number of serious procedure-related adverse events

  Total events within 30 days of Treatment 1 and Treatment 2

• Patient reported outcome measures using SGRQ Total Score

  Time Frame: 6-months post treatment relative to baseline

• Patient reported outcome measures using CAT Total Score

  Time Frame: 6-months post treatment relative to baseline

Study Arms (1)

Metered cryospray (MCS) using the RejuvenAir® System

EXPERIMENTAL

Device: Metered cryospray (MCS)

Interventions

Metered cryospray (MCS) DEVICE

Bronchial metered cryospray (MCS)

Metered cryospray (MCS) using the RejuvenAir® System

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has completed a previous MCS study, including both treatments (treatment day 1 and treatment day 2)
• Males and females \<80 years of age
• Subject is able to read, understand, and sign a written informed consent form in order to participate in the study
• Subject has a diagnosis of chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) for a minimum of two years. (CB is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
• Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of \>30% FEV1 to \<80% predicted with a baseline FEV1/FVC of \<0.70
• Subject is being treated according to current medically accepted treatment guidelines for CB for minimum of 3 months prior to enrollment into the study.
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study
• Subject is able to adhere to and undergo 2 bronchoscopic procedures per hospital guidelines

You may not qualify if:

• Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
• Subject has other origins of respiratory disease aside from CB and COPD
• Subject is using e-cigarettes, vaping or inhaled substances not prescribed by a physician
• Subject has untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
• Subject has bullous emphysema characterized as large bullae \>30 millimeters on High Resolution Computed Tomography (HRCT); or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis
• Subject has clinically significant bronchiectasis as determined by the investigator
• Subject has had a solid organ transplant procedure
• Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
• Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies
• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
• Subject is unable to complete patient reported outcome questionnaires due to cognitive impairment, previous cerebral infarct e.g. stroke, TIA
• Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or uncontrolled gastric reflux
• Subject is pregnant, nursing, or planning to get pregnant during study duration
• Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study
• Subject is or has been in another treatment study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation

Sponsors & Collaborators

• CSA Medical, Inc.: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All eligible subjects will receive Metered Cryospray (MCS) treatment

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03