Status unknownNCT03631472Gala_EFSUpdated May 9, 2022Results posted

Gala Early Feasibility Study of RheOx

An interventional study of RheOx in Chronic Bronchitis and Copd Bronchitis, sponsored by Gala Therapeutics, Inc.. Status unknown at 8 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by Gala Therapeutics, Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 21
Allocation: Not applicable
Ages: 40 Years and older
Sex: All

Study 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 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 studied

Chronic Bronchitis
Copd Bronchitis

Browse trials for

Bronchitis, Chronic 209

In context

Bronchitis, Chronic

209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.

This study's enrollment of 21 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.

Browse Bronchitis, Chronic studies →

Lead sponsor

Gala Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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 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 .

Exclusion criteria

Exclusion Criteria:

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 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.
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 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 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 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.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Experimental
RheOx Treatment
RheOx Treatment (i.e., Bronchial Rheoplasty)
Device: RheOx

Interventions

DeviceRheOx
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.
Also known as: Bronchial Rheoplasty, Gala Airway Treatment System

What researchers measure

Primary outcomes

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.
Time frame: 12 months

Secondary outcomes

Clinical Utility: SGRQ Score at 6 Months
The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.
Time frame: 6 months
Clinical Utility: SGRQ Score at 12 Months
The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: 12 months
Clinical Utility: CAT Total Score at 6 Months
The change from baseline to 6 months in COPD Assessment Test (CAT) total score
Time frame: 6 months
Clinical Utility: CAT Total Score at 12 Months
The change from baseline to 12 months in COPD Assessment Test (CAT) total score
Time frame: 12 months

Other outcomes

Hospitalization Rate
The rate of hospitalizations (events/pt/year)
Time frame: 12 months

Results

Posted May 9, 2022

Participant flow

Participant flow — Overall Study
Milestone	RheOx Treatment
Started	21
Completed	21
Not completed	0

Outcome measures

PrimarySafety 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.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Safety Through 12 Months: Rate of Serious Adverse Events
Participants	RheOx Treatment
Safety Through 12 Months: Rate of Serious Adverse Events	0

SecondaryClinical Utility: SGRQ Score at 6 Months

The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.

Time frame:: 6 months
Reported as:: Mean · units on a scale

Clinical Utility: SGRQ Score at 6 Months
units on a scale	RheOx Treatment
Clinical Utility: SGRQ Score at 6 Months	-13.3 ± 11.7

SecondaryClinical Utility: SGRQ Score at 12 Months

The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score

Time frame:: 12 months
Reported as:: Mean · units on a scale

Clinical Utility: SGRQ Score at 12 Months
units on a scale	RheOx Treatment
Clinical Utility: SGRQ Score at 12 Months	-16.6 ± 13.3

SecondaryClinical Utility: CAT Total Score at 6 Months

The change from baseline to 6 months in COPD Assessment Test (CAT) total score

Time frame:: 6 months
Reported as:: Mean · units on a scale

Clinical Utility: CAT Total Score at 6 Months
units on a scale	RheOx Treatment
Clinical Utility: CAT Total Score at 6 Months	-7.6 ± 5.1

SecondaryClinical Utility: CAT Total Score at 12 Months

The change from baseline to 12 months in COPD Assessment Test (CAT) total score

Time frame:: 12 months
Reported as:: Mean · units on a scale

Clinical Utility: CAT Total Score at 12 Months
units on a scale	RheOx Treatment
Clinical Utility: CAT Total Score at 12 Months	-9.0 ± 6.3

Other pre-specifiedHospitalization Rate

The rate of hospitalizations (events/pt/year)

Time frame:: 12 months

Results for this outcome have not been posted.

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
RheOx Treatment	0/21 (0%)	3/21 (14.3%)	20/21 (95.2%)

Most frequent serious events

Most frequent serious events
Event	RheOx Treatment
pneumoniaRespiratory, thoracic and mediastinal disorders	2/21
COPD exacerbationRespiratory, thoracic and mediastinal disorders	1/21
hyponatremiaBlood and lymphatic system disorders	1/21
stress cardiomyopathyCardiac disorders	1/21
hip fractureMusculoskeletal and connective tissue disorders	1/21

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	RheOx Treatment
COPD exacerbationRespiratory, thoracic and mediastinal disorders	11/21
coughRespiratory, thoracic and mediastinal disorders	9/21
sore throatRespiratory, thoracic and mediastinal disorders	5/21
wheezingRespiratory, thoracic and mediastinal disorders	5/21
headacheNervous system disorders	4/21
lung noduleRespiratory, thoracic and mediastinal disorders	4/21
Chest painGeneral disorders	3/21
hemoptysisRespiratory, thoracic and mediastinal disorders	3/21
GastroenteritisInfections and infestations	2/21
abnormal finding on CT scanInvestigations	2/21

Baseline characteristics

Age, Continuous
Age, Continuous(years)	RheOx Treatment
Mean	66.1 ± 5.2

Sex: Female, Male
Sex: Female, Male(Participants)	RheOx Treatment
Female	9
Male	12

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	RheOx Treatment

Region of Enrollment
Region of Enrollment(participants)	RheOx Treatment
United States	21

FEV1 percentage of Predicted FEV1
FEV1 percentage of Predicted FEV1(percentage)	RheOx Treatment
Mean	53.3 ± 15.8

FEV1/FVC
FEV1/FVC(ratio)	RheOx Treatment
Mean	51.2 ± 14.3

CAT Total Score
CAT Total Score(units on a scale)	RheOx Treatment
Mean	26.9 ± 4.9

SGRQ Total Score
SGRQ Total Score(units on a scale)	RheOx Treatment
Mean	60.1 ± 15.5

Study locations

8 sites

University of Alabama Lung Health Center
Birmingham, Alabama 35249, United States
Mayo Clinic Florida
Jacksonville, Florida 32224, United States
University of Chicago
Chicago, Illinois 60637, United States
University of Iowa
Iowa City, Iowa 52242, United States
MedStar Health
Baltimore, Maryland 21237, United States
Beth Israel Deaconess
Boston, Massachusetts 02215, United States
Temple University School of Medicine
Philadelphia, Pennsylvania 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States

References and documents

Study documents

Study protocol ↗ · May 28, 2019
Statistical analysis plan ↗ · Dec 21, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Jan 2021, 30 months.

Results were first posted in May 2022, 1 year 3 months after primary completion.

Of 24 interventional studies with no phase under Bronchitis, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 47. This study's 30 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 13, 2018
First posted: Aug 15, 2018
StartActual: Jul 6, 2018
Primary completionActual: Jan 30, 2021
CompletionEst.: Dec 30, 2024
Results first posted: May 9, 2022
Last update: May 9, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03631472
Lead sponsor: Gala Therapeutics, Inc.
Responsible party: Sponsor
First posted: Aug 15, 2018
Start date: Jul 6, 2018
Primary completion: Jan 30, 2021
Completion: Dec 30, 2024 (estimated)
Results posted: May 9, 2022
Last update: May 9, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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