Clinical Study of the RheOx Bronchial Rheoplasty System in Treating
the Symptoms of Chronic Bronchitis (Gala RheSolve)

What is Bronchial Rheoplasty?

This is a device therapy being studied for patients with COPD and chronic sputum production. In the study, a small tube called a bronchoscope is placed in the lungs under anesthesia. Through that, a catheter is introduced, and non-heat pulsed electrical stimulation is applied to mucus secreting cells in the lungs. In COPD, there is increased mucus production resulting in shortness of breath and cough. This therapy can potentially reduce mucus production, flare-ups and improve symptoms in patients with COPD.

 

Mucus obstruction resulting in shortness of breath and cough.



RheOx delivers non-thermal pulsed electric fields to the airyways to reduce mucus producing cells in patients with Chronic Bronchitis
Cells regenerate with fewer abnormal cells, therefore producing less mucus


GRS
You might qualify for this if you have:
  • COPD with chronic sputum production
  • On standard inhaler therapy for COPD
  • Have quit smoking for a minimum of 6 months
  • Have significant symptoms of COPD assessed by CAT score

What Will My Role Be in the Study?

If you participate in this study, you will have procedures done on each lung on 2 separate days and will be followed for 2 years, including 4 clinical visits and 4 telephone visits. After consenting, you will complete questionnaires, lab work, EKG, lung function testing, exercise walk test and a CT scan. This will be at no cost and you will be reimbursed up to $1,900 based on which study arm you will be in. If you were assigned to the control arm, you will have a chance to receive the treatment following the completion of your 12-month visit in this study.

To See a Sample Bronchial Rheoplasty Procedure,
Click the Video on the Right

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