A Study to Evaluate RheOx Bronchial Rheoplasty System to Treat Chronic Bronchitis in Adults with COPD


About this study

The purpose of this study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Patient is at least 35 years of age.

2. Patient has chronic bronchitis, defined as productive cough for three months in each
of two successive years, whereas other causes of productive cough have been ruled out.

3. Patient has a CAT score ≥ 10.

4. Patient has an SGRQ score ≥ 25.

5. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points
or the sum is 6 points and the patient's total CAT score is > 20 points.

6. Patient has FEV1/FVC < 0.7.

7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.

8. Patient is receiving guideline directed pharmacotherapy which includes one or more
long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for
at least 8 weeks prior to randomization

9. Patient has a cigarette smoking history of at least ten pack years.

10. In the opinion of the Primary investigator, patient is able to undergo 2
bronchoscopies under general anesthesia and is able to adhere to the study follow-up

Exclusion Criteria:

1. Patient has known unresolved lower respiratory tract infection (e.g., pneumonia,
mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).

2. Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per

3. Patient has any implantable electronic device (e.g., pacemaker, cardioverter
defibrillator, neuro-stimulation devices).

4. Patient has a history of arrhythmia within past two years which includes tachy-atrial
arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate
less than 45 beats per minute.

5. Patient has unresolved lung cancer.

6. Patient has a pulmonary nodule or cavity that in the judgement of the Primary
investigator may require intervention during the course of the study.

7. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung
implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior
pneumothorax without lung resection, pleural procedures without surgery, or
segmentectomy are acceptable.

8. Patient has emphysema of greater than or equal to 20% as quantified on baseline HRCT
scan (low attenuation area less than -950HU) as determined by the CT Core Lab.

9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.

10. Patient has clinically significant bronchiectasis influencing the patient's clinical
symptoms of cough and phlegm.

11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.)
within the last 6 months.

12. Patient is unable to walk over 225 meters in 6 minutes.

13. Patient has a serious medical condition that, in the Primary investigator's opinion,
could compromise patient safety or confound the interpretation of the patient's
response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial
infarction in the past year, renal failure, liver disease cerebrovascular accident
within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension
(diastolic BP >100mmHg) or autoimmune disease requiring treatment with
immunosuppressant medications or a disease requiring chemotherapy).

14. Patient has uncontrolled GERD.

15. Patient has known severe pulmonary hypertension.

16. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e.,
lidocaine, atropine, benzodiazepines).

17. Patient is pregnant, nursing, or planning to get pregnant during study duration.

18. Patient is currently participating in another clinical study involving an
investigational product

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Kern, M.D.

Open for enrollment

Contact information:

Brandon Clapp

(507) 284-2122


Jacksonville, Fla.

Mayo Clinic principal investigator

Sebastian Fernandez-Bussy, M.D.

Open for enrollment

Contact information:

Caroline Chang

(904) 953-4637


More information


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