US-based medical device company Gala Therapeutics is set to begin its pivotal RheSolve clinical trial to evaluate the RheOx Bronchial Rheoplasty System for chronic bronchitis.
RheOx can potentially lessen mucus-producing cells in chronic bronchitis patients.
The latest move comes after the US Food and Drug Administration (FDA) granted conditional Investigational Device Exemption (IDE) approval to conduct the trial.
Gala Therapeutics CEO Jonathan Waldstreicher said: “With the approval of this rigorously designed trial, we are ready to commence enrolment at major medical centres across the US.
“This is a significant milestone towards bringing breakthrough therapy to millions of chronic bronchitis patients in the US.”
The technology consists of an electrosurgical generator and a single-use catheter that collectively provide non-thermal energy to the airways. It reduces abnormal mucus-producing cell number in the lungs, paving a path for the redevelopment of new normal cells.
Conducted using a minimally invasive, bronchoscopic procedure called Bronchial Rheoplasty, the RheOx System could improve cough and mucus symptoms of chronic bronchitis.
The double-blind, randomised, sham-controlled study will analyse the safety and efficacy of the RheOx System for treating bronchitis symptoms in chronic obstructive pulmonary disease (COPD) patients with moderate to severe chronic bronchitis.
It will enrol 270 participants in a 2:1 ratio at up to 40 US centres and up to ten international centres.
The change from baseline to six months in the COPD Assessment Test (CAT) score will form the primary efficacy endpoint of the trial.
The University of Pittsburgh Pulmonary and Critical Care Medicine Division medicine professor and co-principal investigator of the trial Frank Sciurba said: “Chronic bronchitis is a debilitating disease, which results in symptoms that impact the quality of life, which commonly persist following guideline-based medical treatment.
“Prior feasibility study results suggest that Bronchial Rheoplasty using RheOx is well-tolerated, reduces symptoms, and may significantly improve quality of life for patients.”