Bronchial Rheoplasty for Chronic Bronchitis
(RheSolve Trial)

Recruiting in Palo Alto (17 mi)

+39 other locations

Overseen byArschang Valipour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Gala Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective 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. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.

Research Team

Frank Sciurba, MD

Principal Investigator

UPMC; Division of Pulmonary and Critical Care Medicine

Arschang Valipour, MD

Principal Investigator

Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria

Eligibility Criteria

Adults over 35 with moderate to severe chronic bronchitis, a history of smoking, and specific scores on respiratory health questionnaires. They must be on stable medication for at least 8 weeks and able to walk more than 225 meters. Excluded are those with emphysema, asthma, certain heart conditions or devices that can't be turned off during procedures, unresolved lung cancer, recent smokers or other serious medical issues.

Inclusion Criteria

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 schedule

I am 35 years old or older.

You have a CAT score of 10 or higher.

See 7 more

Exclusion Criteria

I have a lung spot that might need treatment during the study.

I need more than 10 mg of oral steroids daily for my condition.

I have an ongoing lung infection that hasn't healed.

See 15 more

Treatment Details

Interventions

RheOx Bronchial Rheoplasty (Procedure)
Sham Procedure (Procedure)

Trial OverviewThe trial is testing the RheOx Bronchial Rheoplasty System against a sham procedure to see if it's safe and effective in treating symptoms of chronic bronchitis in COPD patients. It's randomized and double-blind meaning neither the participants nor the researchers know who receives which treatment until after the results are collected.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RheOx TreatmentExperimental Treatment1 Intervention

Group II: Sham ProcedurePlacebo Group1 Intervention