Chronic BronchitisGala_EFSNCT03631472
Gala Early Feasibility Study of RheOx
A study testing RheOx in people with Chronic Bronchitis and Copd Bronchitis, run by Gala Therapeutics, Inc. at 8 sites in United States.
Trial summary
An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Bronchitis, Copd Bronchitis
- What is being tested?
- RheOx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Jul 2018to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
- Subject responds to the first two questions of the CAT must sum to at least 7 points. If the sum of the first two CAT questions is 6 points and the subject's total CAT score is greater than 20 points, the subject may be enrolled.
- Subject has preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment.
- Subject has had 1 or more COPD exacerbations, defined as an acute worsening in respiratory symptoms that requires additional treatment, in the 12-months prior to enrollment.
- Subject has a SGRQ score of greater than or equal to 25 and CAT score of greater than or equal to 10.
- Subject has a cigarette smoking history of at least ten packs years.
- Subject in the opinion of the site investigator is able to adhere to and undergo two bronchoscopies and has provided a signed informed consent.
Who cannot join
- Subject has lower respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) within the six weeks prior to the initial treatment bronchoscopy or mild or moderate COPD exacerbation (per GOLD guidelines) within 4 weeks of the procedure.
- Subject is taking > 10 mg of prednisolone or prednisone per day.
- Subject has an implantable cardioverter defibrillator or pacemaker.
- Subject has a history of cardiac arrhythmia within past two years.
- Subject has history of unresolved lung cancer in last 5 years.
- Subject has bullous disease as defined by bullae exceeding 3 cm in diameter on HRCT.
Show all 20Show fewer
- Subject has pulmonary nodule or cavity rthat in the judgement of the investigator may require intervention during the course of the study.
- Subject has prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures without surgery are acceptable.
- Subject has clinically significant cardiomyopathy.
- Subject has severe bronchiectasis as outlined in the report of the CT scan of the chest by the interpreting radiologist or in the view of the PI, those findings bronchiectasis or any other significant second lung disease, are the main drivers of the patient's clinical symptoms.
- Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
- Subject has the inability to walk over 100 meters in 6 minutes.
- Subject has clinically significant serious medical conditions, such as: congestive heart failure, angina or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or autoimmune disease.
- Subject has uncontrolled GERD.
- Subject has sever pulmonary hypertension.
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
- Subject is pregnant, nursing, or planning to get pregnant during study duration.
- Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
- Subject is or has been in another clinical investigational study within 6 weeks of baseline.
- Subject on anticoagulation for cardiovascular indications and is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days prior to bronchoscopy in the opinion of the Investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
MedStar Health
Baltimore, Maryland, 21237
University of Alabama Lung Health Center
Birmingham, Alabama, 35249
Beth Israel Deaconess
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic Florida
Jacksonville, Florida, 32224
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Feasibility Study: A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States
An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.
Read the detailed description
RheOx is a device-based, energy delivery system that delivers energy for the ablation of soft tissue such as 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 anesthesia. 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 tests during the study including three CT scans (lung), respiratory function tests, exercise testing.
- Conditions
- Chronic Bronchitis, Copd Bronchitis
- Being tested
- RheOx
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RheOxDevice
Also called Bronchial Rheoplasty, Gala Airway Treatment System
RheOx is a 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 | Experimental | RheOx Treatment (i.e., Bronchial Rheoplasty) Receives: Device: RheOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Through 12 Months: Rate of Serious Adverse Events
Rate of serious adverse events of interest through 12 months. Events of interest are death, COPD exacerbation requiring hospitalization, pneumothrax within 2 days of procedure, pneumonia within 7 days of procedure, respiratory failure or arrhythmia requiring intervention.
Measured: 12 months
Secondary outcomes (4)
Clinical Utility: SGRQ Score at 6 Months
The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.
Measured: 6 months
Clinical Utility: SGRQ Score at 12 Months
The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score
Measured: 12 months
Clinical Utility: CAT Total Score at 6 Months
The change from baseline to 6 months in COPD Assessment Test (CAT) total score
Measured: 6 months
Clinical Utility: CAT Total Score at 12 Months
The change from baseline to 12 months in COPD Assessment Test (CAT) total score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start6 Jul 2018
- Primary completion30 Jan 2021
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment with RheOx
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gala Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631472
- Sponsor's protocol ID
- CS003
- Acronym
- Gala_EFS
- Status last verified
- Apr 2022
- First submitted
- 13 Aug 2018
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Krimsky WS, Mammarappallil JG, Kim V, Bannan B, Charbonnier JP, Hatton BA, Sciurba FC. Airway Mucus Plugging in Chronic Bronchitis and the Impact of Bronchial Rheoplasty. Chest. 2026 Jan;169(1):73-83. doi: 10.1016/j.chest.2025.06.022. Epub 2025 Jun 24.
PubMed 40571054Sciurba FC, Dransfield MT, Kim V, Marchetti N, Comellas A, Hogarth DK, Majid A. Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx. BMJ Open Respir Res. 2023 Dec 26;10(1):e001710. doi: 10.1136/bmjresp-2023-001710.
PubMed 38151258
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study: A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States
- ClinicalTrials.gov ID
- NCT03631472
- Acronym / sponsor ID
- Gala_EFS / CS003
- Conditions
- Chronic Bronchitis, Copd Bronchitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gala Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.
Detailed description
RheOx is a device-based, energy delivery system that delivers energy for the ablation of soft tissue such as 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 anesthesia. 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 tests during the study including three CT scans (lung), respiratory function tests, exercise testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with RheOx
| Arm | Type | Receives |
|---|---|---|
| RheOx Treatment | Experimental | Device: RheOxRheOx Treatment (i.e., Bronchial Rheoplasty) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
- Subject responds to the first two questions of the CAT must sum to at least 7 points. If the sum of the first two CAT questions is 6 points and the subject's total CAT score is greater than 20 points, the subject may be enrolled.
- Subject has preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment.
- Subject has had 1 or more COPD exacerbations, defined as an acute worsening in respiratory symptoms that requires additional treatment, in the 12-months prior to enrollment.
- Subject has a SGRQ score of greater than or equal to 25 and CAT score of greater than or equal to 10.
Key exclusion criteria (20 listed)
- Subject has lower respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) within the six weeks prior to the initial treatment bronchoscopy or mild or moderate COPD exacerbation (per GOLD guidelines) within 4 weeks of the procedure.
- Subject is taking > 10 mg of prednisolone or prednisone per day.
- Subject has an implantable cardioverter defibrillator or pacemaker.
- Subject has a history of cardiac arrhythmia within past two years.
- Subject has history of unresolved lung cancer in last 5 years.
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 |
|---|---|---|
| RheOxAlso: Bronchial Rheoplasty, Gala Airway Treatment SystemRheOx is a 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 Through 12 Months: Rate of Serious Adverse Events
Time frame: 12 months
Rate of serious adverse events of interest through 12 months. Events of interest are death, COPD exacerbation requiring hospitalization, pneumothrax within 2 days of procedure, pneumonia within 7 days of procedure, respiratory failure or arrhythmia requiring intervention.
4 secondary outcomes
Clinical Utility: SGRQ Score at 6 Months
Time frame: 6 months
Clinical Utility: SGRQ Score at 12 Months
Time frame: 12 months
Clinical Utility: CAT Total Score at 6 Months
Time frame: 6 months
Clinical Utility: CAT Total Score at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40571054Krimsky WS, Mammarappallil JG, Kim V, Bannan B, Charbonnier JP, Hatton BA, Sciurba FC. Airway Mucus Plugging in Chronic Bronchitis and the Impact of Bronchial Rheoplasty. Chest. 2026 Jan;169(1):73-83. doi: 10.1016/j.chest.2025.06.022. Epub 2025 Jun 24.
- Derived from this study: PubMed 38151258Sciurba FC, Dransfield MT, Kim V, Marchetti N, Comellas A, Hogarth DK, Majid A. Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx. BMJ Open Respir Res. 2023 Dec 26;10(1):e001710. doi: 10.1136/bmjresp-2023-001710.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: 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 Bronchitis, run by Gala Therapeutics, Inc. at 8 sites in United States.
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 7 inclusion and 20 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Through 12 Months: Rate of Serious Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631472, which also lists 2 linked publications.
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 9 May 2022.