The RheSolve Study
Research type
Research Study
Full title
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD
IRAS ID
312382
Contact name
Pallav Shah
Contact email
Sponsor organisation
Gala Therapeutics, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
RheOx is an investigational treatment intended for patients with chronic bronchitis. It is believed that the symptoms of chronic bronchitis, which are mainly cough and phlegm (mucus) production, are associated with abnormal mucus cells in the bronchi (airway passages) of the lungs. Although drugs that make the airways larger (bronchodilators) are used to treat the symptoms of chronic bronchitis, they do not treat the underlying disease.
Bronchial Rheoplasty (investigational treatment) is designed to remove the tissue layers of the airway where the abnormal mucus cells are located. It is expected the airway tissue will heal more normally after treatment, and thereby reduce the symptoms associated with chronic bronchitis, such as cough and phlegm.
The purpose of the 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.
This study is sponsored by Gala Therapeutics, Inc, based in US.
A total of 270 patients will be randomizeed in the study at up to 40 United States study centers and up to 10 centers outside the US (Canada and Europe). A maximum of 90 patients (33% of the total study population) will be randomized outside the United States.
They will be involved for 2 years.
Clinical sites and study investigators will be chosen to participate in this study based on their qualifications and experience.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0169
Date of REC Opinion
5 Sep 2022
REC opinion
Further Information Favourable Opinion