Trial Outcomes & Findings for Gala Early Feasibility Study of RheOx (NCT NCT03631472)
NCT ID: NCT03631472
Last Updated: 2022-05-09
Results Overview
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.
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
12 months
Results posted on
2022-05-09
Participant Flow
Participant milestones
| Measure |
RheOx Treatment
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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21
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
RheOx Treatment
n=21 Participants
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Age, Continuous
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66.1 years
STANDARD_DEVIATION 5.2 • n=21 Participants
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Sex: Female, Male
Female
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9 Participants
n=21 Participants
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Sex: Female, Male
Male
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12 Participants
n=21 Participants
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Region of Enrollment
United States
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21 participants
n=21 Participants
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FEV1 percentage of Predicted FEV1
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53.3 percentage
STANDARD_DEVIATION 15.8 • n=21 Participants
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FEV1/FVC
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51.2 ratio
STANDARD_DEVIATION 14.3 • n=21 Participants
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CAT Total Score
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26.9 units on a scale
STANDARD_DEVIATION 4.9 • n=21 Participants
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SGRQ Total Score
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60.1 units on a scale
STANDARD_DEVIATION 15.5 • n=21 Participants
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PRIMARY outcome
Timeframe: 12 monthsRate 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.
Outcome measures
| Measure |
RheOx Treatment
n=21 Participants
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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Safety Through 12 Months: Rate of Serious Adverse Events
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0 Participants
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SECONDARY outcome
Timeframe: 6 monthsThe change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.
Outcome measures
| Measure |
RheOx Treatment
n=20 Participants
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Clinical Utility: SGRQ Score at 6 Months
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-13.3 units on a scale
Standard Deviation 11.7
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SECONDARY outcome
Timeframe: 12 monthsThe change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score
Outcome measures
| Measure |
RheOx Treatment
n=21 Participants
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Clinical Utility: SGRQ Score at 12 Months
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-16.6 units on a scale
Standard Deviation 13.3
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SECONDARY outcome
Timeframe: 6 monthsThe change from baseline to 6 months in COPD Assessment Test (CAT) total score
Outcome measures
| Measure |
RheOx Treatment
n=20 Participants
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Clinical Utility: CAT Total Score at 6 Months
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-7.6 units on a scale
Standard Deviation 5.1
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SECONDARY outcome
Timeframe: 12 monthsThe change from baseline to 12 months in COPD Assessment Test (CAT) total score
Outcome measures
| Measure |
RheOx Treatment
n=21 Participants
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Clinical Utility: CAT Total Score at 12 Months
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-9.0 units on a scale
Standard Deviation 6.3
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OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsThe rate of hospitalizations (events/pt/year)
Outcome measures
Outcome data not reported
Adverse Events
RheOx Treatment
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RheOx Treatment
n=21 participants at risk
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
pneumonia
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9.5%
2/21 • Number of events 2 • 1 year
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Respiratory, thoracic and mediastinal disorders
COPD exacerbation
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4.8%
1/21 • Number of events 1 • 1 year
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Blood and lymphatic system disorders
hyponatremia
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4.8%
1/21 • Number of events 1 • 1 year
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Cardiac disorders
stress cardiomyopathy
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4.8%
1/21 • Number of events 1 • 1 year
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Musculoskeletal and connective tissue disorders
hip fracture
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4.8%
1/21 • Number of events 1 • 1 year
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Other adverse events
| Measure |
RheOx Treatment
n=21 participants at risk
RheOx Treatment (i.e., Bronchial Rheoplasty)
RheOx: 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.
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|---|---|
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General disorders
Chest pain
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14.3%
3/21 • Number of events 3 • 1 year
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Infections and infestations
Gastroenteritis
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9.5%
2/21 • Number of events 2 • 1 year
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Investigations
abnormal finding on CT scan
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9.5%
2/21 • Number of events 2 • 1 year
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Nervous system disorders
headache
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19.0%
4/21 • Number of events 4 • 1 year
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Renal and urinary disorders
urinary retention
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9.5%
2/21 • Number of events 2 • 1 year
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Respiratory, thoracic and mediastinal disorders
COPD exacerbation
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52.4%
11/21 • Number of events 11 • 1 year
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Respiratory, thoracic and mediastinal disorders
cough
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42.9%
9/21 • Number of events 9 • 1 year
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Respiratory, thoracic and mediastinal disorders
hemoptysis
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14.3%
3/21 • Number of events 3 • 1 year
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Respiratory, thoracic and mediastinal disorders
lung nodule
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19.0%
4/21 • Number of events 4 • 1 year
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Respiratory, thoracic and mediastinal disorders
sore throat
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23.8%
5/21 • Number of events 5 • 1 year
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Respiratory, thoracic and mediastinal disorders
wheezing
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23.8%
5/21 • Number of events 5 • 1 year
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Additional Information
James Stambaugh SVP of Clinical Affairs
Gala Therapeutics
Phone: 4087186834
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place