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Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RheOx | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of SAEs | Incidence of serious adverse events associated with RheOx treatment through 24 months | Through end of study (24 months post bilateral treatment) |
| Quality of Life: CAT | COPD Assessment Test (CAT) questionnaire | Through end of study (24 months post bilateral treatment) |
| Quality of Life: SGRQ | St. George Respiratory Questionnaire | Through end of study (24 months post-bilateral treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function: FEV1 | Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second. | Through end of study (24 months post-bilateral treatment) |
| Pulmonary Function: FVC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeff Keeney | Contact | 650-268-4252 | jeff@galatherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| William Krimsky, MD | Gala Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otto Wagner Spital | Recruiting | Vienna | A-1140 | Austria |
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| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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RheOx Treatment
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Forced Vital Capacity
| Through end of study (24 months post-bilateral treatment) |
| COPD Exacerbations | COPD Exacerbations | Through end of study (24 months post-bilateral treatment) |
| Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg | Recruiting | Heidelberg | Baden-Wurttemberg | 69047 | Germany |
|
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |