Gala Early Feasibility Study of RheOx (Gala_EFS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03631472|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Results First Posted : May 9, 2022
Last Update Posted : May 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Bronchitis Copd Bronchitis||Device: RheOx||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Treatment with RheOx|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study: A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States|
|Actual Study Start Date :||July 6, 2018|
|Actual Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||December 30, 2024|
Experimental: RheOx Treatment
RheOx Treatment (i.e., Bronchial Rheoplasty)
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.
- 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.
- Clinical Utility: SGRQ Score at 6 Months [ Time Frame: 6 months ]The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score.
- Clinical Utility: SGRQ Score at 12 Months [ Time Frame: 12 months ]The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score
- Clinical Utility: CAT Total Score at 6 Months [ Time Frame: 6 months ]The change from baseline to 6 months in COPD Assessment Test (CAT) total score
- Clinical Utility: CAT Total Score at 12 Months [ Time Frame: 12 months ]The change from baseline to 12 months in COPD Assessment Test (CAT) total score
- Hospitalization Rate [ Time Frame: 12 months ]The rate of hospitalizations (events/pt/year)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631472
|United States, Alabama|
|University of Alabama Lung Health Center|
|Birmingham, Alabama, United States, 35249|
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|Baltimore, Maryland, United States, 21237|
|United States, Massachusetts|
|Beth Israel Deaconess|
|Boston, Massachusetts, United States, 02215|
|United States, Pennsylvania|
|Temple University School of Medicine|
|Philadelphia, Pennsylvania, United States, 19140|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|