RheOx Registry Study in Europe
RheOx European Post-Market Clinical Study
1 other identifier
interventional
100
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 2, 2019
CompletedStudy Start
First participant enrolled
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedMarch 22, 2022
March 1, 2022
4.9 years
November 27, 2019
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Safety: Incidence of SAEs
Incidence of serious adverse events associated with RheOx treatment through 24 months
Through end of study (24 months post bilateral treatment)
Quality of Life: CAT
COPD Assessment Test (CAT) questionnaire
Through end of study (24 months post bilateral treatment)
Quality of Life: SGRQ
St. George Respiratory Questionnaire
Through end of study (24 months post-bilateral treatment)
Secondary Outcomes (3)
Pulmonary Function: FEV1
Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FVC
Through end of study (24 months post-bilateral treatment)
COPD Exacerbations
Through end of study (24 months post-bilateral treatment)
Study Arms (1)
RheOx Treatment
OTHERRheOx 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient has moderate to severe Chronic Bronchitis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Otto Wagner Spital
Vienna, A-1140, Austria
Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69047, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Krimsky, MD
Gala Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2019
First Posted
December 2, 2019
Study Start
January 9, 2020
Primary Completion
December 15, 2024
Study Completion
December 15, 2025
Last Updated
March 22, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share