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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
Sponsor:
Information provided by (Responsible Party):
Gala Therapeutics, Inc.

Study Description
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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 Intervention/treatment Phase
Chronic Bronchitis COPD Device: RheOx Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: RheOx Treatment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
RheOx Treatment
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.
 Device: RheOx
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Quality of Life: CAT [ Time Frame: Through end of study (24 months post bilateral treatment) ]
    COPD Assessment Test (CAT) questionnaire

  3. Quality of Life: SGRQ [ Time Frame: Through end of study (24 months post-bilateral treatment) ]
    St. George Respiratory Questionnaire


Secondary Outcome Measures :
  1. 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.

  2. Pulmonary Function: FVC [ Time Frame: Through end of study (24 months post-bilateral treatment) ]
    Forced Vital Capacity

  3. COPD Exacerbations [ Time Frame: Through end of study (24 months post-bilateral treatment) ]
    COPD Exacerbations


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jeff Keeney 650-268-4252 jeff@galatherapeutics.com

Locations
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Austria
Otto Wagner Spital Recruiting
Wien, Austria, A-1140
Contact: Kelly Gross    0043 664 4385355    blvr.koordinator@gmail.com   
Principal Investigator: Arschang Valipour, MD         
Germany
Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69047
Contact: Brigitte Rump    49 (6221) 396-1211    brigitte.rump@med.uni-heidelberg.de   
Principal Investigator: Felix Herth, MD         
Sponsors and Collaborators
Gala Therapeutics, Inc.
Investigators
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Study Director: William Krimsky, MD Gala Therapeutics, Inc.
More Information
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Responsible Party: Gala Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04182841    
Other Study ID Numbers: CS005
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

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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
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Disease Attributes
Pathologic Processes