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Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis

NCT04677465 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2023-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Bronchitis

Interventions

DEVICE

RheOx Bronchial Rheoplasty

bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.

DEVICE

Sham Procedure

staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)

Sponsors & Collaborators

  • Gala Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frank Sciurba, MD · UPMC; Division of Pulmonary and Critical Care Medicine

  • Arschang Valipour, MD · Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2024-05-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677465 on ClinicalTrials.gov