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

NAActive, not recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

April 7, 2021

Primary Completion Date

May 31, 2024

Study Completion Date

October 31, 2025

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)

Trial Locations (37)

1210

Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie, Vienna

13353

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

19140

Temple University, Philadelphia

23298

Virginia Commonwealth University Health, Richmond

25123

ASST Spedali Civili Hospital, Brescia

28374

Pinehurst Medical Clinic, Pinehurst

30322

Emory University, Atlanta

32224

Mayo Clinic, Jacksonville

32605

The Cardiac and Vascular Institute Research Foundation, Tallahassee

35233

University of Alabama at Birmingham, Birmingham

37212

Vanderbilt University Medical Center, Nashville

37404

CHI Memorial Research Center, Chattanooga

39216

University of Mississippi, Jackson

45239

Ruhrlandklinik Essen, Essen

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

55407

Minnesota Lung Center, Minneapolis

55905

Mayo Clinic, Rochester

61637

OSF Saint Francis Medical Center, Peoria

66160

University of Kansas School of Medicine, Kansas City

69126

Thoraxklinik Heidelberg, Heidelberg

70112

Tulane University Medical Center, New Orleans

76104

JPS Health Network, Fort Worth, Fort Worth

77030

Houston Methodist, Houston

80045

University of Colorado, Aurora

85013

Norton Thoracic, Phoenix

85258

Honor Health, Scottsdale

90033

University of Southern California, Los Angeles

90502

UCLA Harbor Lundquist Institute, Torrance

92024

Scripps Health, Encinitas

93309

Syed M. Alam, MD Pulmonology (Bakersfield Heart), Bakersfield

95817

UC Davis Medical Center, Davis

02215

Beth Israel Deaconess Medical Center, Boston

01805

Lahey Hospital and Medical Center, Burlington

SW3 6NP

Royal Brompton Hospital, London

Sponsors
All Listed Sponsors
lead

Gala Therapeutics, Inc.

INDUSTRY