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NCT04182841 | RECRUITING | Chronic Bronchitis

RheOx Registry Study in Europe
Sponsor:

Gala Therapeutics, Inc.

Brief Summary:

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

Condition or disease

Chronic Bronchitis

COPD

Intervention/treatment

RheOx

Phase

NA

Detailed Description:

RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies. Subjects will be required to submit to several tests and questionnaires during the study including respiratory function tests.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : RheOx European Post-Market Clinical Study
Actual Study Start Date : 2020-01-09
Estimated Primary Completion Date : 2024-12-15
Estimated Study Completion Date : 2025-12-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient has moderate to severe Chronic Bronchitis
Exclusion Criteria
  • * Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device.
  • * Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block.
  • * Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.
RheOx Registry Study in Europe

Location Details

NCT04182841

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Austria,

Otto Wagner Spital

Vienna, Austria, A-1140

RECRUITING

Germany, Baden-Württemberg

Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg

Heidelberg, Baden-Württemberg, Germany, 69047