RheOx Registry Study in Europe
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04182841|
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : March 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Bronchitis COPD||Device: RheOx||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||RheOx Treatment|
|Masking:||None (Open Label)|
|Official Title:||RheOx European Post-Market Clinical Study|
|Actual Study Start Date :||January 9, 2020|
|Estimated Primary Completion Date :||December 15, 2024|
|Estimated Study Completion Date :||December 15, 2025|
RheOx is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
RheOX is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
- Safety: Incidence of SAEs [ Time Frame: Through end of study (24 months post bilateral treatment) ]Incidence of serious adverse events associated with RheOx treatment through 24 months
- Quality of Life: CAT [ Time Frame: Through end of study (24 months post bilateral treatment) ]COPD Assessment Test (CAT) questionnaire
- Quality of Life: SGRQ [ Time Frame: Through end of study (24 months post-bilateral treatment) ]St. George Respiratory Questionnaire
- Pulmonary Function: FEV1 [ Time Frame: Through end of study (24 months post-bilateral treatment) ]Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.
- Pulmonary Function: FVC [ Time Frame: Through end of study (24 months post-bilateral treatment) ]Forced Vital Capacity
- COPD Exacerbations [ Time Frame: Through end of study (24 months post-bilateral treatment) ]COPD Exacerbations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient has moderate to severe Chronic Bronchitis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182841
|Contact: Jeff Keeneyfirstname.lastname@example.org|
|Otto Wagner Spital||Recruiting|
|Wien, Austria, A-1140|
|Contact: Kelly Gross 0043 664 4385355 email@example.com|
|Principal Investigator: Arschang Valipour, MD|
|Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg||Recruiting|
|Heidelberg, Baden-Württemberg, Germany, 69047|
|Contact: Brigitte Rump 49 (6221) 396-1211 firstname.lastname@example.org|
|Principal Investigator: Felix Herth, MD|
|Study Director:||William Krimsky, MD||Gala Therapeutics, Inc.|
|Responsible Party:||Gala Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 2, 2019 Key Record Dates|
|Last Update Posted:||March 22, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive