Chronic BronchitisNCT04182841
RheOx Registry Study in Europe
A study testing RheOx in people with Chronic Bronchitis and COPD, run by Gala Therapeutics, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Bronchitis, COPD
- What is being tested?
- RheOx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Jan 2020to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has moderate to severe Chronic Bronchitis
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Otto Wagner Spital
Vienna, A-1140
Kelly Gross, 0043 664 4385355, blvr.koordinator@gmail.com
Arschang Valipour, MD
Germany1 site, 1 recruiting
- Recruiting
Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69047
Brigitte Rump, 49 (6221) 396-1211, brigitte.rump@med.uni-heidelberg.de
Felix Herth, MD
About this study
Official title: RheOx European Post-Market Clinical Study
Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
Read the 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.
- Conditions
- Chronic Bronchitis, COPD
- Being tested
- RheOx
- Medical subject headings
- Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RheOxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RheOx Treatment | Other | 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. Receives: Device: RheOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of SAEs
Incidence of serious adverse events associated with RheOx treatment through 24 months
Measured: Through end of study (24 months post bilateral treatment)
Quality of Life: CAT
COPD Assessment Test (CAT) questionnaire
Measured: Through end of study (24 months post bilateral treatment)
Quality of Life: SGRQ
St. George Respiratory Questionnaire
Measured: Through end of study (24 months post-bilateral treatment)
Secondary outcomes (3)
Pulmonary Function: FEV1
Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.
Measured: Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FVC
Forced Vital Capacity
Measured: Through end of study (24 months post-bilateral treatment)
COPD Exacerbations
COPD Exacerbations
Measured: Through end of study (24 months post-bilateral treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start9 Jan 2020
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- RheOx Treatment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gala Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Krimsky, MD, Study director, Gala Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182841
- Sponsor's protocol ID
- CS005
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RheOx European Post-Market Clinical Study
- ClinicalTrials.gov ID
- NCT04182841
- Acronym / sponsor ID
- CS005
- Conditions
- Chronic Bronchitis, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gala Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RheOx Treatment
| Arm | Type | Receives |
|---|---|---|
| RheOx Treatment | Other | Device: RheOxRheOx 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient has moderate to severe Chronic Bronchitis
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RheOxRheOX 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 Treatment |
Primary outcome
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
3 secondary outcomes
Pulmonary Function: FEV1
Time frame: Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FVC
Time frame: Through end of study (24 months post-bilateral treatment)
COPD Exacerbations
Time frame: Through end of study (24 months post-bilateral treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Krimsky, MD study director
Gala Therapeutics, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RheOx in people with Chronic Bronchitis and COPD, run by Gala Therapeutics, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff Keeney (650-268-4252, jeff@galatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of SAEs (time frame: Through end of study (24 months post bilateral treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.